NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under
FDA device recall Z-0757-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Welch Allyn Inc
- Reason for recall
- GMP deficiencies
- Action taken
- Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXQ
- Distribution
- Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.
- Date initiated
- 2004-03-01
- Date posted
- 2004-07-20
- Date terminated
- 2005-09-01
- Location
- Skaneateles Falls, NY
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