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Terminated

VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362

FDA Recall Z-0849-2020 · Posted None

Recalling FirmVitreq Bv
Recall StatusTerminated
Product CodeGAA
Date Initiated2019-12-17
Date Terminated2020-12-09

Reason for Recall

Microscopic tears of the sterile pouch may compromise sterility

Firm 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 [email protected]. If you have any specific product replacement questions you may contact Customer Service Team at: [email protected] or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).

Root Cause

Package design/selection

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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