Recall Z-1804-2015 ยท FSY Light, Surgical, Ceiling Mounted
Beaver-Visitec International Inc.
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
| Date | Jun 15, 2015 (initiated May 1, 2015) |
| Status | Terminated |
| Reason | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product |
| Root cause | 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 | 585 kits |
| Distribution | Nationwide Distribution including KY, GA, MI, and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.