Welch Allyn Inc NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-1 - Arden, Skaneateles, NY. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-1 - Arden, Skaneateles, NY.
Brand
Welch Allyn Inc
Lot Codes / Batch Numbers
Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)
Products Sold
Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)
Welch Allyn Inc is recalling NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient u due to GMP deficiencies. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
GMP deficiencies
Recommended Action
Per FDA guidance
Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026