Z-1610-2015Class III

Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for...

Name: Z-1610-2015 Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for...
Creator: Zimmer Surgical Inc
Published: 2015-04-21
License: https://open.fda.gov/license/

Zimmer Surgical SA / initiated 2015-04-21 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Surgical Inc began a recall of Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage on 2015-04-21. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1610-2015
Classification: Class III
Status: Terminated
Initiated: 2015-04-21
Posted: 2015-05-13
Terminated: 2015-11-06
Recalling firm: Zimmer Surgical SA
Product: Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
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.
Root cause tag: labeling and UDI
FDA 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 [email protected] and the affected product to the address provided. A credit will be issued for unused devices upon receipt. Questions regarding this information should be directed to 330-364-0989.
Quantity in commerce: 36 units
Distribution: Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.
Product codes and lots: Item #00-2568-000-10; Lot #62800843

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1610-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1610-2015	Class III	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-13

Product code GCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)