Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes

BOULDER, CO–(ENEWSPF)–April 24, 2010.Covidien (NYSE: COV) has initiated a voluntaryrecall of certain lots of its cuffed ShileyTM tracheostomy tubes andCustom/Specialty tracheostomy tubes due to the product’s cuff not holding air asa result of leaks in the pilot balloon inflation assembly. With respect to theaffected units, if a cuff does not hold air, ventilation will be adverselyaffected since the ability to generate positive pressure in the airway could becompromised by lack of cuff seal. This could result in a sudden decrease in theamount of oxygen in the blood or a sudden increase in the amount of carbondioxide in the blood, especially if the patient requires assisted mechanicalventilation. In some instances, this could result in serious injury, includingdeath.

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

Table 1 – ShileyTMTracheostomyProducts

Item

Starting
LotNumber

Ending
LotNumber

Item

Starting
LotNumber

Ending
LotNumber

Item

Starting
LotNumber

Ending
LotNumber

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 areclearly 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 othertracheostomy tubes, the lot number can be found on the carton and pouch or traylid.

For the products listed in Table 1 above: Products with lot codes where the first four numbers are in the range from 0810to 0908 may be affected; consult Table 1 for specific lot code ranges for eachproduct code. Products in the above Table 1 with lot code numbers starting with0809 or lower, and those with lot code numbers starting with 0909 or higher, arenot affected.

Table 2 – Custom ShileyTM TracheostomyProducts

MSCT

0904000093

0912001647

M5SCT

0907000415

0908002263

M5.5SCT

0907000880

0907002499

M6SCT

0904000093

0908002249

M6.5.SCT

0904000511

0908000714

M7SCT

0904000118

0908001971

M7.5SCT

0904000602

0908001068

M8SCT

0904000132

0910001376

M9SCT

0904001119

0912001647

M10SCT

0905001247

0908000752

 

MPDC

0904001545

0905000593

M4.0PDC

0904001545

0905000593

M5.5PDC

0905000552

n/a

 

MPLC

0905000553

n/a

M5.5PLC

0905000553

n/a

 

MFEN

0908001420

0912000048

M6FEN

0908001420

0910000004

M8FEN

0909000850

0912000048

MLPC

0908001982

0912000321

M6LPC

0908001982

0912000321

M8LPC

0909000673

0911001672

 

MDCT

0911000199

0911000221

M6DCT

0911000221

n/a

M8DCT

0911000199

n/a

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

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

Customers were notified of this issue by a CustomerNotification letter April 13, 2010, which is posted at http://respiratorysolutions.covidien.com/AirwayManagement/tabid/234/Default.aspx1. Then click on the Product Noticestab.

The company believes it has taken appropriate stepsto address this issue. Adequate supplies of unaffected replacement product areavailable.

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

Healthcare professionals and customers may reportadverse events or quality problems experienced with the use of this product tothe FDA’s MedWatch Adverse Event Reporting program either online, by regularmail, fax or by phone.

Source:fda.gov