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U.S. Department of Health and Human Services

Class 2 Device Recall SafeCut Safety Scalpels

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  Class 2 Device Recall SafeCut Safety Scalpels see related information
Date Initiated by Firm June 24, 2014
Date Posted April 14, 2015
Recall Status1 Terminated 3 on November 05, 2015
Recall Number Z-1443-2015
Recall Event ID 70822
Product Classification Handle, scalpel - Product Code GDZ
Product Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
Code Information Lot numbers: 1174108,1174108,1174108D,1174108D,1174108D,1174108D,1174108D,1174108D,1175108,1175108,1175108,1175108,1175108,1194108,1194108,1194108,1194108D,1194108D,1194108D,1194108D,1194108D,1194118,1194118,1194118,1194118,1194118,1275108,1275108,1275108,1275108,1275108D,1275108D,1275108D,1275108D,1275108D,1295108,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108FD,1295108FD,1295118,1295118,1295118,1295118,1295118,1385108Q,1385108QD,1385108QD,1385108QD,1385108QD,1386108,1386108D,1386108D,1395108QD,1395108QD,1396118,2194108,2194108,2295108,3154108,3154108,3174108,3174108,3174108,3174108,3174108d,3175108,3194108,3194108D,3255108,3255108,3255108,3255108,3274108,3275108,3275108d,3275108d,3295108,3295108,3295108,3295108d,3295108FD,3295108FD,3385108Q,3385108QD,3385108QD,3385108QD,3386108,3386108,3386108,3386108d,3395108Q,3395108QD,3395108QD,3396108,3396118,4154108,4154108,4154108,4154108D,4154108D,4154108D,4154108D,4154108D,4154108D,5575240,5605150,5605150,5605150,5605200,5605200,5605200,5605200,5605240,5605240,5605300,5605300,5615150,5615150,5615150,5615150,5615150,5615200,5615200,5615200,5625150,5625150,5625240,5655200,5755200,5766150,5766150,6174108,6194108,6194108,6194118,6194118,6295108,6295108,9173108,9173108D,9174108,9174108,9194108,9194108,9194108,9194108D,9275108d,9275108d,9275108f,9275108f,9275108f,9295108fd,9295108fd,9385108Q,9385108Q,9385108QD,9385108QD,9385108QD,9395108QD,9395108QD,9395108QD,9395118Q,9717308,
Recalling Firm/
Bard Access Systems
605 North 5600 West
Salt Lake City UT 84116-3738
For Additional Information Contact Brenda Shelkey
Manufacturer Reason
for Recall
Potential for inadvertent scalpel stick injury involving the safety scalpel.
FDA Determined
Cause 2
Component change control
Action Bard sent an Urgent Notification letter date June 26, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed on the proper device use and safety mechanism activation of the Safe-Cut Safety Scalpel. For questions call coordinator, Shelly Gilbert, at 1-800-290-1689.
Quantity in Commerce 51,025 units
Distribution Worldwide Distribution - US Nationwide
Total Product Life Cycle TPLC 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.