RegWardenFDA facility compliance records
Recall

Class II — B. Braun Medical, Inc.

Recalling firmB. BRAUN MEDICAL INC.
Registered facilityView this company's 5 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonOne lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.
ProductB. 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.
Quantity55,200 units
DistributionUSA Nationwide Distribution including Puerto Rico.
Initiated2013-09-27
Classified2013-12-20
Terminated2014-10-08
Recall numberZ-0559-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — B. Braun Medical, Inc. (Z-0559-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66535/

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