| Class 3 Device Recall 100 mL Hemovac Mini Evacuator | |
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
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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
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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 |
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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.
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