Covidien Recals Certain Shiley Tracheostomy Tubes

RECALLS, MARKET WITHDRAWALS, & SAFETY ALERTS ARCHIVE FOR RECALLS, MARKET WITHDRAWALS & SAFETY ALERTS ENFORCEMENT REPORTS INDUSTRY GUIDANCE MAJOR PRODUCT RECALLS – RECALL — FIRM PRESS RELEASE

FDA POSTS PRESS RELEASES AND OTHER NOTICES OF RECALLS AND MARKET WITHDRAWALS FROM THE FIRMS INVOLVED AS A SERVICE TO CONSUMERS, THE MEDIA, AND OTHER INTERESTED PARTIES. FDA DOES NOT ENDORSE EITHER THE PRODUCT OR THE COMPANY.

COVIDIEN INITIATES VOLUNTARY RECALL OF CERTAIN SHILEYâ„¢ TRACHEOSTOMY TUBES

COMPANY CONTACT:
SHERRI HUGHES-SMITH
MANAGER, MEDIA AND PUBLIC RELATION
RESPIRATORY AND MONITORING SOLUTIONS
303-581-6849
SHERRI.HUGHES-SMITH@COVIDIEN.COM

BRUCE FARMER
VICE PRESIDENT
PUBLIC RELATIONS
508-452-4372
BRUCE.FARMER@COVIDIEN.COM

COLEMAN LANNUM, CFA VICE PRESIDENT
INVESTOR RELATIONS
508-452-4343
COLE.LANNUM@COVIDIEN.COM

BRIAN NAMETH
DIRECTOR
INVESTOR RELATIONS
508-452-4363
BRIAN.NAMETH@COVIDIEN.COM

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 

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  

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