BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
This recall has been terminated (originally issued June 15, 2015).
- Recall Initiated
- May 1, 2015
- Posted
- June 15, 2015
- Terminated
- January 28, 2021
- Recall Number
- Z-1803-2015
- Quantity
- 384 kits
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
Distribution
Nationwide Distribution including KY, GA, MI, and NJ.
Lot / Code Info
Lot Numbers: 3038787 3046210 3061080 3078492 3093681 3095940 3108668
Root Cause
Nonconforming Material/Component
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.
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