Date Initiated by Firm | May 01, 2015 |
Date Posted | June 15, 2015 |
Recall Status1 |
Terminated 3 on January 28, 2021 |
Recall Number | Z-1803-2015 |
Recall Event ID |
71293 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
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Product | BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove
Part Number: 584648
Ophthalmic surgical kits |
Code Information |
Lot Numbers: 3038787 3046210 3061080 3078492 3093681 3095940 3108668 |
Recalling Firm/ Manufacturer |
Beaver-Visitec International Inc. 411 Waverley Oaks Rd Ste 229 Waltham MA 02452-8422
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For Additional Information Contact | SAME 781-906-7950 |
Manufacturer Reason for Recall | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Beaver-Visitec International Sales Ltd. (BVI) sent an Urgent Field Safety Notice dated May 2, 2015, to all affected customers. Customers were instructed to quarantine the affected kits and return to BVI for subsequent replacement of product. A Verification Form was provided to confirm receipt of the recall notice. For questions regarding this recall call 791-906-7950. |
Quantity in Commerce | 384 kits |
Distribution | Nationwide Distribution including KY, GA, MI, and NJ. |
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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