Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall 100 mL Hemovac Mini Evacuator

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall 100 mL Hemovac Mini Evacuator see related information
Date Initiated by Firm April 21, 2015
Date Posted May 13, 2015
Recall Status1 Terminated 3 on November 06, 2015
Recall Number Z-1610-2015
Recall Event ID 71057
Product Classification Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
Product Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc.

Intended for post-operative collection of wound drainage.
Code Information Item #00-2568-000-10; Lot #62800843
Recalling Firm/
Manufacturer		 Zimmer Surgical Inc
200 W Ohio Ave
Dover OH 44622-9642
For Additional Information Contact Customer Service
330-364-0989
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-