FDA Recall
Terminated
NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn label with Part #5082-101-1, and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - firm on label is Welch Allyn, Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #30502-110S, firm on label is Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #5084-101-1, firm on label is Arden, Skaneateles, NY.
Recall: Z-0748-04
·
Initiated March 1, 2004
Recall
- Recall Number
- Z-0748-04
- Event Number
- 28428
- Firm
- Welch Allyn Inc
- FEI Number
- 1316463
- Product Code
- DXQ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 1, 2004
- Posted
- July 20, 2004
- Terminated
- September 1, 2005
- Address
- 4341 State Street Rd, Skaneateles Falls, NY, 13153-5300
Description
NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn label with Part #5082-101-1, and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - firm on label is Welch Allyn, Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #30502-110S, firm on label is Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #5084-101-1, firm on label is Arden, Skaneateles, NY.
Reason
GMP deficiencies
Action
Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.
Distribution
Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.