Recall Z-1610-2015 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Zimmer Surgical Inc
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
| Date | May 13, 2015 (initiated Apr 21, 2015) |
| Status | Terminated |
| Reason | Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units. |
| Root cause | Other |
| Action | On 4/28/2015 the firm sent Urgent: Medical Device Removal letters to their customers. The letters identified the affected product in addition to stating that the reason for the recall is due to missing Instructions for Use from sales units. The letters discussed the clinical implications or risk to health, and actions required. Customers are to review the notification, identify and quarantine the affected product to prevent further distribution or use, and return the completed response form to CorporateQuality.PostMarket@zimmer.com and the affected product to the address provided. A credit |
| Quantity | 36 units |
| Distribution | Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.