T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84
FDA device recall Z-0934-03 · posted 2003-06-17 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD
- Reason for recall
- The irrigation set was mislabeled with the wrong delivery rate of 8 drops/mL when it actually has a delivery rate of 11 drops/mL
- Action taken
- Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 60 units
- Distribution
- New Orleans, LA
- Date initiated
- 2003-05-13
- Date posted
- 2003-06-17
- Date terminated
- 2003-11-20
- Location
- Abbott Park, IL
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