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Terminated

Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery

FDA Recall Z-2342-2018 · Posted None

Recalling FirmBeaver Visitec
Recall StatusTerminated
Product CodeEMF
Date Initiated2018-05-14
Date Terminated2021-06-08
Product Quantity1354 units

Reason for Recall

Blades are loose in handles and may fall out due to non cured epoxy

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide in the states of CA, IA, CO, HI, IA, MD & TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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