FDA Medical Device Recalls (openFDA)
Bard Access Systems: Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
- Recall number
- Z-1443-2015
- Recalling firm
- Bard Access Systems
- Product
- Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
- Status
- Terminated
- Initiated
- 2014-06-24
- Posted
- 2015-04-14
- Terminated
- 2015-11-05
- Reason
- Potential for inadvertent scalpel stick injury involving the safety scalpel.
- Root cause
- 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
- 51,025 units
- Distribution
- Worldwide Distribution - US Nationwide
- Lot, serial or model codes
- 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,
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDZ
- Firm FEI
- 3006260740
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28