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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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