Recall Z-2342-2018 ยท EMF Knife, Surgical
Beaver Visitec
Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
| Date | May 14, 2018 |
| Status | Terminated |
| Reason | Blades are loose in handles and may fall out due to non cured epoxy |
| Root cause | Nonconforming Material/Component |
| Action | On May 14, 2018, Beaver-Visitec International (BVI) issued PRODUCT RECALL NOTICES to customers. Customers were advised to take the following actions: -Inspect stock, quarantine and destroy product per internal procedures. -Complete and return the response form via email to claimsus@bvimedical.com - Provide objective evidence of product destruction with BVI so that credit to customer accounts can be applied. Customers with questions may contact the firm by calling 866-906-8080. |
| Quantity | 1354 units |
| Distribution | US Nationwide in the states of CA, IA, CO, HI, IA, MD & TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.