Recall Z-1457-2008 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Zimmer Inc.
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-003-10; 400 ml evacuators and 450 ml collection bags, 3/16 in. (15 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, soft, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio
| Date | Apr 9, 2008 (initiated Jan 31, 2008) |
| Status | Terminated |
| Reason | Leakage; The kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use. |
| Root cause | Process control |
| Action | Consignees were notified via Urgent Infection Control Recall letter dated 1/31/08 to examine their inventory and return the recalled lots. Custom kit packers were instructed in the same letter to recall these products/lots from their own customers. |
| Quantity | 34,354 (Recalls Z-1448/1458-2008) |
| Distribution | Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.