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Product Recalls April 2010-Dec 2011

The FDA issues recalls FDA
see FDA enforcement report as well as recalls, alerts and warnings

The Regulatory Affairs Professional Society RAPS
regularly post FDA's Center for Devices and Radiological Health (CDRH) news and recall information.

Product recalls April 2010 through Dec 2011

Certain Cuffed Shiley Tracheostomy Tubes

Company, Product(s): Shiley Inflatable Cuff Tracheostomy Tubes

Recall Class: Class I

Date Recall Initiated: April 13, 2010

Product Names:

These tubes were distributed between November 2008 and September 2009.

The following link provides a chart with all Shiley inflatable cuff tracheostomy tubes that are part of this recall: http://www.fda.gov/Safety/Recalls/ucm209709.htm

Use:

Tracheostomy tubes are prescription devices used by the order of a physician.

A tracheostomy is a surgical procedure to create an opening through the neck into the windpipe (trachea). A tracheostomy tube is usually placed through the windpipe to provide an airway and to provide a pathway to remove fluid from the trachea and lungs.

Inflatable cuff tracheostomy tubes have a soft balloon around the far end of the tube that is inflated to seal off the space between the wall of the windpipe and the tracheostomy tube during mechanical ventilation. The cuff prevents air from the ventilator from leaking around the tracheostomy tube and prevents injury to delicate tissue in the windpipe.

Recalling Firm:

Nellcor Puritan Bennett Inc., doing business as Covidien Ltd.
6135 Gunbarrel Avenue
Boulder, Colorado 80301-3214

Reason for Recall: The company has voluntarily recalled this device because they may leak air, resulting in inadequate ventilation.

This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death.

Public Contact: If you need assistance or have questions about this recall or your cuffed Shiley tracheostomy tubes, call Covdien Nellcor Puritan Bennett Customer Service available 24 hours a day, 7 days a week at 1-800-635-5267.

FDA District: Denver

FDA Comments:

Customers were notified of this recall by the company in a letter on April 13, 2010. The letter includes advice for healthcare facilities as well as patients and non-clinical caregivers. The letter is available on the Covidien website at http://respiratorysolutions.covidien.com/LinkClick.aspx? fileticket=GTn1%2f3%2f6cko%3d&tabid=234.Exit Disclaimer

Any adverse reactions experienced with the use of this product or quality problems may be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Useful Links:

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Cook Medical - Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley Tracheostomy Tube

Recall Class: Class I

Date Recall Initiated: April 21, 2010

Products: Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley Tracheostomy Tube

To see the specific reorder numbers and global part numbers for the products affected by this recall, please see the firm press release below under Useful Links.

These sets and trays were distributed from February 18, 2009 through April 27, 2010.

Use: The tracheostomy sets and trays are prescription devices used by the order of a physician.

A tracheostomy is a surgical procedure to create an opening through the neck into the windpipe (trachea). A tracheostomy tube is usually placed through the windpipe to provide an airway and to provide a pathway to remove fluid from the trachea and lungs.

Inflatable cuff tracheostomy tubes have a soft balloon around the far end of the tube that is inflated to seal off the space between the wall of the windpipe and the tracheostomy tube during mechanical ventilation. The cuff prevents air from the ventilator from leaking around the tracheostomy tube and prevents injury to delicate tissue in the windpipe.

Recalling Firm:

Cook, Inc.
750 Daniels Way
Bloomington, Indiana 47404-9120

Reason for Recall:

These sets and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been the subject of a recall. Such tubes may leak air, resulting in inadequate ventilation. Use of these products can result in serious injury, including death.

Public Contact:

Customers may contact Cook Medical Customer Relations Department at 1-800-457-4500 or 1-812-339-2235, or by email at This email address is being protected from spambots. You need JavaScript enabled to view it..

FDA District: Detroit

FDA Comments:

Cook Medical sent their recall notice to hospitals, other user facilities, and to distribution centers. The company directed hospitals to return the affected products, and the distribution centers to stop distributing the products and to notify their customers. For additional information, see the firm’s press release below.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by FAX.

Useful Links:

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FOR IMMEDIATE RELEASE - April 23, 2010 – BOULDER, CO - Covidien (NYSE: COV) has initiated a voluntary recall of certain lots of its cuffed ShileyTM tracheostomy tubes and Custom/Specialty tracheostomy tubes due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. With respect to the affected units, if a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal. This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death.

The voluntary recall only affects lot numbers from a specific period of time. Only Shiley tracheostomy tubes from lot numbers listed below are affected by this action. Customers should review product in inventory and current use to identify product from the affected lot codes. Detailed steps are provided in the Customer Notification letter for return and disposition of affected product.

Table 1 - ShileyTMTracheostomy Products 

 

Item

Starting
Lot Number

Ending
Lot Number

 

Item

Starting
Lot Number

Ending
Lot Number

 

Item

Starting
Lot Number

Ending
Lot Number

4DCT

0810002426

0908000766

 

6FEN-S

0811000211

0907001570

 

4LPC-S

0905000105

n/a

6DCT

0810002428

0908000773

 

8FEN-S

0811001529

0908000791

 

6LPC-S

0810002449

0906000342

8DCT

0810002433

0908000787

 

 

 

 

 

8LPC-S

0901002066

0907002156

10DCT

0811000171

0908000765

 

4LPC

0810002441

0908000768

 

10LPC-S

0812000912

0907000367

 

 

 

 

6LPC

0810002442

0908000780

 

 

 

 

4FEN

0811001522

0908000767

 

8LPC

0810000069

0908000792

 

4.0PDC

0903000859

0908001790

6FEN

0810002445

0908000776

 

10LPC

0811001521

0907001560

 

4.5PDC

0903000861

0908000693

8FEN

0810002447

0908000256

 

 

 

 

 

5.0PDC

0903000862

0908001208

10FEN

0811001364

0908000233

 

5SCT

0906000823

0907001067

 

5.5PDC

0903000863

0908001211

 

 

 

 

6SCT

0903001835

0908000124

 

 

 

 

4DFEN

0811001526

0908000235

 

7SCT

0903000809

0908002300

 

5.0PLC

0903000865

0907001065

6DFEN

0810002448

0908000774

 

8SCT

0903000810

0908001215

 

5.5PLC

0903001839

0907001066

8DFEN

0811000185

0908000789

 

9SCT

0905001770

0907001068

 

6.0PLC

0903000866

0908001213

10DFEN

0812000028

0908000232

 

10SCT

0907002007

0908001339

 

6.5PLC

0903000867

0907001525

6PERC

0810002450

0908000782

8PERC

0810002453

0908000797

The lot numbers for all Shiley dual cannula tracheostomy tubes are clearly printed on the left side of the Soft Swivel Flange and on the carton and pouch or tray lid, depending on the product configuration. For all other tracheostomy tubes, the lot number can be found on the carton and pouch or tray lid.

For the products listed in Table 1 above: Products with lot codes where the first four numbers are in the range from 0810 to 0908 may be affected; consult Table 1 for specific lot code ranges for each product code. Products in the above Table 1 with lot code numbers starting with 0809 or lower, and those with lot code numbers starting with 0909 or higher, are not affected.  

Table 2 – Custom ShileyTM Tracheostomy Products  

 

MSCT

0904000093

0912001647

 

MPDC

0904001545

0905000593

 

MLPC

0908001982

0912000321

M5SCT

0907000415

0908002263

 

M4.0PDC

0904001545

0905000593

 

M6LPC

0908001982

0912000321

M5.5SCT

0907000880

0907002499

 

M5.5PDC

0905000552

n/a

 

M8LPC

0909000673

0911001672

M6SCT

0904000093

0908002249

 

 

 

 

 

 

 

 

M6.5.SCT

0904000511

0908000714

 

MPLC

0905000553

n/a

 

MDCT

0911000199

0911000221

M7SCT

0904000118

0908001971

 

M5.5PLC

0905000553

n/a

 

M6DCT

0911000221

n/a

M7.5SCT

0904000602

0908001068

 

 

 

 

 

M8DCT

0911000199

n/a

M8SCT

0904000132

0910001376

 

MFEN

0908001420

0912000048

 

 

 

 

M9SCT

0904001119

0912001647

 

M6FEN

0908001420

0910000004

 

 

 

 

M10SCT

0905001247

0908000752

 

M8FEN

0909000850

0912000048

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 The lot number of Custom/Specialty tracheostomy tubes is clearly printed on the left side of the Soft Swivel Flange and on the carton and pouch in which the product was shipped. 

 For the products listed in Table 2 above: Products with lot codes where the first four numbers are in the range from 0904 to 0912 may be affected; consult Table 2 for specific lot code ranges for each product code. Products in the above Table 2 with lot code numbers starting with 0903 or lower, and those with lot code numbers starting with 1001 or higher, are not affected.  

Customers were notified of this issue by a Customer Notification letter April 13, 2010, which is posted at http://respiratorysolutions.covidien.com/AirwayManagement/tabid/234/Default.aspx. Then click on the Product Notices tab. 

The company believes it has taken appropriate steps to address this issue. Adequate supplies of unaffected replacement product are available. 

To return the affected product for credit, contact Technical Services group at 1-800-635-5267, option 3, then option 1, and reference the Return Goods Authorization (RGA) Number.  

Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or by phone.  

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CareFusion AVEA Ventilator

Recall Class: Class I

Date Recall Initiated: September 8, 2011

Product: AVEA ventilators manufactured between March 1, 2009 and June 30, 2011.

Use: The AVEA ventilator is intended for continuous breathing support for the care of neonatal through adult patients who require mechanical ventilation. These ventilators are used in hospitals and other health care institutions.

Recalling Firm:

CareFusion 211, Inc.
22745 Savi Ranch Parkway
Yorba Linda, California 92887

Reason for Recall: The AVEA ventilator can develop a failure where the ventilator activates a false Extended High Ppeak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer life-threatening injury or death.

CareFusion has received a total of 94 reports of incidents in which the ventilator has apparently malfunctioned. No deaths or injuries were reported.

Public Contact: Affected customers with questions may contact the CareFusion Recall Support Center, toll-free: 1-888-562-6018.

FDA District: Los Angeles

FDA Comments: CareFusion notified customers via recall notice on September 15, 2011 with a follow-up letter on October 4, 2011. The recall notice stated that the CareFusion Recall Support Center is contacting customers to arrange for onsite remediation of the affected devices.

Customers were also instructed to follow these steps if any AVEA ventilator in their facility exhibits a sustained Extended High Ppeak alarm followed by the opening of the safety valve:

  1. Remove the ventilator from service
  2. Provide alternate ventilation
  3. Contact CareFusion Technical Support at 1-800-231-2466 to report the issue

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm either online, by regular mail, by telephone, or by FAX.

Additional Information:

-----------------------------------

Respironics, Inc. Trilogy 100 Ventilators

Recall Class: Class I

Date Recall Initiated: October 11, 2011

Product: Trilogy 100 ventilators manufactured from February 1, 2011 to April 30, 2011.

Use: The Respironics Trilogy 100 ventilator is intended for continuous or intermittent breathing support for the care of pediatric patients, weighing at least 11 pounds, through adult patients who require mechanical ventilation. The ventilators are used in hospitals, nursing homes and other health care settings, and in the home.

Serial Numbers:

TV111021835 TV111031420 TV111032905 TV111032935
TV111022832 TV111031462 TV111032906 TV111032938
TV111030853 TV111031554 TV111032909 TV111032939
TV111030932 TV111032809 TV111032912 TV111032940
TV111030947 TV111032811 TV111032913 TV111033001
TV111030976 TV111032812 TV111032914 TV111033004
TV111030978 TV111032822 TV111032920 TV111033005
TV111031001 TV111032827 TV111032923 TV111033006
TV111031011 TV111032829 TV111032924 TV111033009
TV111031037 TV111032830 TV111032925 TV111033010
TV111031045 TV111032832 TV111032926 TV111033016
TV111031403 TV111032833 TV111032929 TV111033018
TV111031413 TV111032901 TV111032934 TV111033019

Recalling Firm:

Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8517

Reason for Recall: Trilogy 100 ventilators are being recalled due to a manufacturing issue. This issue can cause part of the blower that circulates air and other gases through the ventilator to move out of position and cause the device to alarm and stop delivering therapy to the patient. In the event of a blower failure, the ventilator will stop delivering therapy and a high priority alarm will sound to alert the caregiver to immediately respond. Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.

Public Contact: Affected customers with questions may contact Respironics Customer Service, toll-free, at: 1-877-387-3311.

FDA District: Philadelphia

FDA Comments:

Respironics notified its United States distributors, providers, sales personnel and customers of the recall by telephone on October 11, 2011. The company will continue to work with affected customers to arrange for the return or repair of all recalled ventilators.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Adverse reactions and/or quality problems should also be reported to Respironics at 1-877-387-3311.

-------------------------------------------------

Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes

Recall Class: Class I

Date Recall Initiated: November 28, 2011

Product: Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes with the integrated connector that does not require use of a disconnect wedge (TR3), manufactured from August 29, 2009 to January 29, 2011.

Lot Numbers 1631477 through 1923406 only.

Use: The Bivona Pediatric, Neonatal and Flextend tracheostomy tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. This product is used in health care facilities and home care environment.

Recalling Firm:
Smiths Medical ASD, Inc.
5700 W 23rd Avenue
Gary, Indiana 46406

Reason for Recall: Some customers have experienced difficulty disconnecting accessories from the connectors of the affected tubes. If excessive force is used to detach the accessory, the tracheostomy tube may dislodge from the patient. This could lead to serious patient injury or death, especially if no replacement tube is immediately available.

Public Contact: Affected customers with questions may contact Smiths Medical Customer Service (Monday – Friday 8am-8pm CST): 1-800-258-5361, Option 1.

FDA District: Detroit

FDA Comments: Smiths Medical mailed all U.S. consignees an Urgent Field Safety Notice on November 28, 2011 and an updated Urgent Field Safety Notice dated Dec 22, 2011 on Janurary 9, 2012. A copy of the customer notification letter, along with pictures to distinguish the affected tubes, is posted on the Smiths Medical website at http://www.smiths-medical.com.

Smiths Medical has instructed consumers who have the affected tubes to:

          1. Identify all affected, unused product in inventory and segregate it to a quarantine location.
          2. Complete the Confirmation Form and return it by Fax to 219-989-7259 or by email to This email address is being protected from spambots. You need JavaScript enabled to view it..
          3. Upon receipt of your completed Confirmation Form, Customer Service will contact you with a Return Material Authorization Number (RMA#), and will schedule the shipment of a replacement Bivona® Neonatal, Pediatric and Flextend Pediatric Tracheostomy Tubes. If you are opting to return the product, credit will be issued upon receipt of the returned product.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, by telephone, or by FAX.

 -------------------------------------------

Dec. 23, 2011-OTTAWA, Dec. 23 (UPI) --Medical devices provider Smiths Medical is voluntarily recalling some lots of Bivona Neonatal, Pediatric and Flextend Tracheotomy Tubes, Canadian officials say.

The company said some customers have experienced difficulty disconnecting accessories from the connectors of the affected devices. Smiths Medical said it was recalling only lot numbers 1631477 through 1923406 of its Bivona, Neonatal, Pediatric and Flextend Tracheotomy Tubes.

A tracheotomy is an opening in the trachea made to help a patient breathe after surgery or if there is a blockage in the airway. The kits are used to help keep the opening clear and clean, officials at Health Canada said.

Some customers were unable to disconnect the accessory, or excessive force led to removal of the tube. Pulling a tube out can result in a life-threatening situation, and emergency intervention by experts may be required in some cases to reinsert the tube and prevent suffocation, Smiths Medical said.

Canadians who care for an infant or child who uses this device, and have purchased or used Bivona Neonatal, Pediatric and Flextend Tracheotomy Tubes, should consult their healthcare practitioners, Health Canada officials said.

Contact Smiths Medical at 905-477-2000 ext. 135 with any questions -- or visit the company's Web site, complete the "Confirmation Form" and return it to the company by fax to 905-477-2144 or by e-mail to This email address is being protected from spambots. You need JavaScript enabled to view it..

Read more: http://www.upi.com/Health_News/2011/12/23/Recall-Some-lots-of-tracheotomy-tubes/UPI-42861324682470/#ixzz1qYJjVLYE

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