Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
FDA device recall Z-1443-2015 · posted 2015-04-14 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- Potential for inadvertent scalpel stick injury involving the safety scalpel.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- GDZ
- Quantity affected
- 51,025 units
- Distribution
- Worldwide Distribution - US Nationwide
- Date initiated
- 2014-06-24
- Date posted
- 2015-04-14
- Date terminated
- 2015-11-05
- Location
- Salt Lake City, UT
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