Z-1443-2015Class II

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

Name: Z-1443-2015 Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety...
Creator: Bard Access Systems
Published: 2014-06-24
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2014-06-24 / Terminated

FDA source

Bard Access Systems began a recall of Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels on 2014-06-24. FDA classified it as Class II and gives the reason as "Potential for inadvertent scalpel stick injury involving the safety scalpel". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1443-2015
Classification: Class II
Status: Terminated
Initiated: 2014-06-24
Posted: 2015-04-14
Terminated: 2015-11-05
Recalling firm: Bard Access Systems, Inc.
Product: Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
Product code: GDZ Handle, Scalpel
Reason for recall: Potential for inadvertent scalpel stick injury involving the safety scalpel.
FDA 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 in commerce: 51,025 units
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: 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,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1443-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1443-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-13

Product code GDZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)