Zimmer Hemovac Mini Evacuator Recalled for Missing Instructions for Use
Zimmer Surgical Inc is recalling 36 units of the 100 mL Hemovac Mini Evacuator because the shipper carton contained only one Instructions for Use (IFU) instead of one per sales unit.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging/documentation error (missing IFU) with no reported injuries.
Plain-English summary
Zimmer Surgical Inc is recalling 36 units of the 100 mL Hemovac Device Hemovac Mini Evacuator (Item #00-2568-000-10, Lot #62800843). The devices are intended for post-operative collection of wound drainage.
The recall was initiated because the devices were placed in a shipper carton without the appropriate number of Instructions for Use (IFU). Packaging specifications require that each sales unit be accompanied by an IFU, but only one IFU was present in the shipper carton instead of one for each of the two sales units.
The affected units were distributed worldwide, including the United States (AZ, CA, ID, IL, MD, NC, RI, and SC) and Canada. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
- Manufacturer
- Zimmer Surgical Inc
- Hazard
- Affected units
- 36
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Item #00-2568-000-10
- Lot #62800843
Distribution
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