NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-102-2, 5082-102-2CL, 671-5082-102-2, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-111 and 30502-211 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-102-2 and 634-5084-102-2 - Arden, Skaneateles, NY.
- Company
- Welch Allyn Inc
- Recall Initiated
- March 1, 2004
- Posted
- July 20, 2004
- Terminated
- September 1, 2005
- Recall Number
- Z-0751-04
- Firm Location
- Skaneateles Falls, NY
Reason for Recall
GMP deficiencies
Distribution
Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.
Lot / Code Info
Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)
Root Cause
Other
Action Taken
Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.
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