NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable one piece cuff, for single patient use only. Sold und
FDA device recall Z-0244-04 · posted 2003-12-18 · Terminated
Recall details
- Recalling firm
- Welch Allyn Inc
- Reason for recall
- Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading.
- Action taken
- Letters dated October 27, 2003 to wholesalers/ distributors with instructions to remove/return product and notify end users.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXQ
- Quantity affected
- 26190
- Distribution
- The product was sold thru 11 distributors. The product was shipped to end users nationwide. There is one foreign distributor in Singapore. In addition, Welch Allyn shipped product to their affiliates
- Date initiated
- 2003-10-27
- Date posted
- 2003-12-18
- Date terminated
- 2005-09-01
- Location
- Skaneateles Falls, NY
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