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Terminated

BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits

FDA Recall Z-1803-2015 · Posted 2015-06-15

Recalling FirmBeaver-Visitec International Inc.
Recall StatusTerminated
Product CodeFSY
Date Initiated2015-05-01
Date Terminated2021-01-28
Product Quantity384 kits

Reason for Recall

Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution including KY, GA, MI, and NJ.

Official Source

View FDA Recall →

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

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