BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical
FDA device recall Z-1802-2015 · posted 2015-06-15 · Terminated
Recall details
- Recalling firm
- Beaver-Visitec International Inc.
- Reason for recall
- Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
- Action taken
- 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
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 621 kits
- Distribution
- Nationwide Distribution including KY, GA, MI, and NJ.
- Date initiated
- 2015-05-01
- Date posted
- 2015-06-15
- Date terminated
- 2021-01-28
- Location
- Waltham, MA
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