B. Braun Recalls Nonsterile Perifix Catheter Connectors Due to Leakage Risk
B. Braun Medical is recalling 60,000 nonsterile Perifix catheter connectors because they may not stay closed, causing leakage or disconnection.
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 medical device with a functional defect (leakage/disconnection) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
B. Braun Medical, Inc. is recalling 60,000 units of Bulk Nonsterile Perifix Catheter Connectors (Material Number 8451699N). These connection devices are used by physicians to provide a single access point to a catheter for the delivery of anesthetics and fluids.
The recall was initiated because the catheter connectors may not stay closed during use. In some cases, leakage or disconnection of the catheters from the connectors has been observed. The affected products were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait.
Healthcare facilities and users should stop using the affected connectors and contact B. Braun Medical for further instructions. The specific batch numbers involved are 61606422, 61605072, 61607144, 61618276, and 61621554.
The recalled product
- Product
- BULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunct
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 60,000
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 (5)
- Batch: 61606422
- 61605072
- 61607144
- 61618276
- 61621554
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 93 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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