AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number
Summary
The FDA issued a Class II for AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, by B. Braun Medical, Inc.. Reason: Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly .
Details
Source
Device Recall
External ID
Z-3144-2024
Action Date
2024-09-25
Status
Ongoing
Category
device
Product Description
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
Lot/Code Info: Model No 472036; UDI-DI 04046964184659; Lots 0061898815, 0061905158, 00VL872690, 00VL882317 and 00VL882319
Quantity Affected: 19050 units
Reason for Recall
Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-08
Company
Allentown, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
B. Braun Medical, Inc. has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B. Braun Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B. Braun Medical, Inc. have FDA actions?
B. Braun Medical, Inc. has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3144-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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