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Terminated

Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.

FDA Recall Z-1443-2015 · Posted 2015-04-14

Recalling FirmBard Access Systems
Recall StatusTerminated
Product CodeGDZ
Date Initiated2014-06-24
Date Terminated2015-11-05
Product Quantity51,025 units

Reason for Recall

Potential for inadvertent scalpel stick injury involving the safety scalpel.

Firm 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.

Root Cause

Component change control

Distribution Pattern

Worldwide Distribution - US Nationwide

Official Source

View FDA Recall →

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

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