Recall Z-0562-04 ยท KOD Catheter, Urological
C.R. Bard, Inc., Urological Division
BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated Foley Catheter, Waterproof underpad, Synthetic Vinyl Gloves (2), Lubricant, 10cc Syringe (prefilled with sterile water to inflate Foley catheter), Povidone-Iodine swabs (3), CSR Wrap, Plastic Tray. C
| Date | Feb 27, 2004 (initiated Feb 10, 2004) |
| Status | Terminated |
| Reason | The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling. |
| Root cause | Other |
| Action | Consignees were notified by certified mail on 02/10/2004. |
| Quantity | 1100 units (110 cases) |
| Distribution | AL, CA, CO, FL, GA, IL, IN, KY, MO, MS, NJ, NY, OH, PA, TX and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.