CLASS III Device recall · Reported 20 May 2015 · FDA Enforcement Report
Zimmer Hemovac Device Hemovac Mini Evacuator recalled by Zimmer Surgical
Zimmer Surgical is recalling Zimmer Hemovac Device Hemovac Mini Evacuator, distributed in 8 states. The recall was initiated on 21 Apr 2015 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1610-2015
- FDA event ID
- 71057
- Recalling firm
- Zimmer Surgical, Dover, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Apr 2015
- FDA classified
- 13 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 21 Apr 2015 | Recall initiated by company | |
| 13 May 2015 | Classified by FDA | +22 days |
| 20 May 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
Where it was distributed
Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.
ArizonaCaliforniaIdahoIllinoisMarylandNorth CarolinaRhode IslandSouth Carolina
Questions about this recall
Is Zimmer Hemovac Device Hemovac Mini Evacuator recalled?
Yes. Zimmer Surgical recalled Zimmer Hemovac Device Hemovac Mini Evacuator on 21 Apr 2015. The recall is Class III and its status is Terminated. Recall number Z-1610-2015.
Why was it recalled?
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.
Which lots are affected?
Item #00-2568-000-10; Lot #62800843
Where was it sold?
Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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