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U.S. Department of Health and Human Services

Class 2 Device Recall Safety Sideport Knife

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 Class 2 Device Recall Safety Sideport Knifesee related information
Date Initiated by FirmMay 14, 2018
Create DateJuly 02, 2018
Recall Status1 Terminated 3 on June 08, 2021
Recall NumberZ-2342-2018
Recall Event ID 80311
Product Classification Knife, surgical - Product Code EMF
ProductSafety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
Code Information Lot Numbers: 6002436 & 6002663
FEI Number 1211998
Recalling Firm/
Manufacturer		 Beaver Visitec
500 Totten Pond Rd
10 City Point
Waltham MA 02451-1916
For Additional Information ContactMax Cox
781-906-8080
Manufacturer Reason
for Recall		Blades are loose in handles and may fall out due to non cured epoxy
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 in Commerce1354 units
DistributionUS Nationwide in the states of CA, IA, CO, HI, IA, MD & TX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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