FDA Recall
Terminated
Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
Recall: Z-2342-2018
·
Initiated May 14, 2018
Recall
- Recall Number
- Z-2342-2018
- Event Number
- 80311
- Firm
- Beaver Visitec
- FEI Number
- 1211998
- Product Code
- EMF
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- May 14, 2018
- Terminated
- June 8, 2021
- Address
- 500 Totten Pond Rd, 10, City Point Waltham, MA, 02451-1916
Description
Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
Reason
Blades are loose in handles and may fall out due to non cured epoxy
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 [email protected] - 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.
Distribution
US Nationwide in the states of CA, IA, CO, HI, IA, MD & TX
Quantity
1354 units