FDA Recall Terminated

VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485

Recall: Z-0854-2020 · Initiated December 17, 2019

Recall

Recall Number
Z-0854-2020
Event Number
84661
Firm
Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands
FEI Number
3012037425
Product Code
HMX
Status
Terminated
Root Cause
Package design/selection
Initiated
December 17, 2019
Terminated
December 9, 2020

Description

VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485

Reason

Microscopic tears of the sterile pouch may compromise sterility

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).

Distribution

Nationwide