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 |
Ending |
Item |
Starting |
Ending |
Item |
Starting |
Ending |
||
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.
- Online: www.fda.gov/medwatch/report.htm2
- Regular Mail: use postage-paid FDAform 3500 available at: www.fda.gov/MedWatch/getforms.htm3. Mail to MedWatch 5600 Fishers Lane,Rockville, MD 20852-9787
- Fax: 1-800-332-0178
- Phone: 1-800-332-1088
Source:fda.gov