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.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Welch Allyn Inc
- Recall Initiated
- March 1, 2004
- Posted
- July 20, 2004
- Terminated
- September 1, 2005
- Recall Number
- Z-0748-04
- Firm Location
- Skaneateles Falls, NY
- Official Source
- View on FDA website ↗
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.
More recalls by Welch Allyn Inc
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body t...
Jul 20, 2021
ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models)
Model: 34X...
Apr 22, 2021
GS777 Wall Transformer
Model: 77710
Intended Use: The GS777 Wall Transformer is intended...
Apr 22, 2021