BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76I
FDA device recall Z-0562-04 · posted 2004-02-27 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc., Urological Division
- Reason for recall
- The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling.
- Action taken
- Consignees were notified by certified mail on 02/10/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- KOD
- Quantity affected
- 1100 units (110 cases)
- Distribution
- AL, CA, CO, FL, GA, IL, IN, KY, MO, MS, NJ, NY, OH, PA, TX and WA.
- Date initiated
- 2004-02-10
- Date posted
- 2004-02-27
- Date terminated
- 2004-07-09
- Location
- Covington, GA
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