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Recall Observatory FDA recall evidence

Device 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.

Z-0559-2014

September 27, 2013

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 66535
Status
Terminated
Classification
Class II
Quantity
55,200 units
Official record key
device-enforcement:Z-0559-2014

Official wording

Reason: One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.

Code information: lot no. 3C30258317

Distribution pattern: USA Nationwide Distribution including Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.