The Recall Desk
HighFDA (Devices)·Z-0559-2014·Announced 2014-01-01

B. Braun IV Catheters Recalled for Missing Safety Clip

B. Braun Medical is recalling 55,200 Introcan Safety IV Catheters because one lot may lack the anti-needlestick safety clip.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a missing safety feature designed to prevent needlestick injuries, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

B. Braun Medical, Inc. is recalling 55,200 units of Introcan Safety IV Catheters, catalog number 4251601-02. The affected product is a 24G, 0.7X19mm-US catheter used for venous or arterial access to infuse fluids, drugs, or blood components.

The recall is due to a manufacturing defect where one lot (lot no. 3C30258317) may not contain the anti-needlestick safety clip. This clip is a passive safety device designed to prevent needlestick injuries to healthcare workers. The FDA has classified this as a Class II recall.

The affected units were distributed nationwide in the United States, including Puerto Rico. Healthcare facilities and users should check their inventory for the specific lot number and stop using any affected catheters.

The recalled product

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
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — IV Catheters
Hazard
Affected units
55,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • lot no. 3C30258317

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · B. Braun Medical, Inc.

See all →

Same hazard · needlestick injury

See all →