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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 17, 2019
Create Date January 24, 2020
Recall Status1 Terminated 3 on December 09, 2020
Recall Number Z-0849-2020
Recall Event ID 84661
Product Classification Needle, aspiration and injection, disposable - Product Code GAA
Product VitreQ 23G PFC Injection Needle- Ref: MD23.D01
GTIN: 8719214221362
Code Information All lots
Recalling Firm/
Manufacturer		 Vitreq Bv
Seggelant-Noord 2
Vierpolders Netherlands
For Additional Information Contact Robin Rowe
269-806-5779
Manufacturer Reason
for Recall		 Microscopic tears of the sterile pouch may compromise sterility
FDA Determined
Cause 2		 Package design/selection
Action VitreQ issued Urgent Medical Device recall dated 12/16/19 letter states reason for recall, health risk and action to take: 1.Immediately examine your inventory and quarantine product from all lots subject to recall. If you have further distributed this product, please identify your customers and notify them at once of this product recall. Consider all potential users of this product in your user supply chain. You may provide a copy of this recall notification letter; 2.Complete the Attachment 1: Response Form enclosed IMMEDIATELY, as evidence of the product being returned, and we will credit your account or complete the response form even if you do not have product to return.3.Return the Attachment 1: Response Form to BVI by one of these methods: Fax 866-906-4304 or email a copy to Claims_US@bvimedical.com. If you have any specific product replacement questions you may contact Customer Service Team at: Claims_US@bvimedical.com or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).
Distribution Nationwide
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.
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