Anesthesia Extension Sets recalled due to potential Spin Lock connector leakage
B. Braun Medical is recalling 19,050 AET36 Anesthesia Extension Sets due to potential product leakage from the Spin Lock Connector caused by excess solvent migration during manufacturing.
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: This is an FDA Class II medical device recall due to a manufacturing defect creating potential product failure through leakage. No illnesses or injuries have been reported. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' receiving a High rating.
Plain-English summary
B. Braun Medical, Inc. is recalling the AET36 Anesthesia Extension Set (Model 472036). The device features a normally closed dual manifold with a four-way stopcock. The recall addresses a potential for product leakage from the Spin Lock Connector on the distal end of the device. This leakage risk results from excess solvent migration that may occur during the manufacturing assembly process.
Approximately 19,050 units are affected. The affected product lot numbers are: 0061898815, 0061905158, 00VL872690, 00VL882317, and 00VL882319. The recalled devices were distributed nationwide throughout the United States.
The recalled product
- Product
- AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 19,050
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 (6)
- Model No 472036
- UDI-DI 04046964184659
- Lots 0061898815
- 0061905158
- 00VL872690
- 00VL882317 and 00VL882319
Distribution
Distributed nationwide across the United States.
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