FDA Device recall Z-1610-2015
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10
- FDA Device
- Class III
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class III recall of Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10 by Zimmer Surgical, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1610-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-04-21 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer Surgical |
| Distribution | AZ, CA, ID, IL, MD, NC, RI, SC |
Product
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
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.
Identifiers
| code_info | Item #00-2568-000-10; Lot #62800843 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1610-2015%22
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