Recall Z-1496-2008 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Zimmer Inc.
Zimmer Hemovac Wound Drainage Device, Infection Control Kits, Mini-Hemovac I.C. Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2557-000-10.
| Date | Sep 19, 2008 (initiated Jan 29, 2008) |
| Status | Terminated |
| Reason | The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging. |
| Root cause | Packaging process control |
| Action | Consignees were notified via recall letter dated 1/29/08 to locate and return the affected product. The recall action was expanded to additional products/lots via recall letter dated 3/17/08. Custom kit packers were instructed to notify their customers. |
| Quantity | 102,813 mini-hemovac systems |
| Distribution | Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.