Z-0559-2014Class II

B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02

Name: Z-0559-2014 B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02
Creator: B. Braun Medical, Inc.
Published: 2013-09-27
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2013-09-27 / Terminated / root cause: labeling and UDI

FDA source

B. Braun Medical, Inc. began a recall of B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive... on 2013-09-27. FDA classified it as Class II and gives the reason as "One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0559-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-27
Posted: 2013-12-21
Terminated: 2014-10-08
Recalling firm: B Braun Medical Inc
Product: B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into vascular system.
Product code: DYB Introducer, Catheter
Reason for recall: One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: B. Braun sent an Urgent Medical Device Recall Notification letter dated September 27, 2013 to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to utilize the attached "Product Removal Acknowledgement Form" to record the number of individual units in their inventory and fax the completed form to 610-848-1197. To ensure proper credit for affected product, customers were instructed to return the product to B. Braun Medical Inc. For questions contact Customer Support Department at 800-227-2862.
Quantity in commerce: 55,200 units
Distribution: USA Nationwide Distribution including Puerto Rico.
Product codes and lots: lot no. 3C30258317

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0559-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0559-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-20

Product code DYB

K021094Class IIIntrocan Safety IV CatheterB.Braun Medical, Inc. / cleared 2002-07-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)