Extension Set recallZ-3144-2024 · B. Braun Medical, Inc. · initiated Aug 8, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B. Braun Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process change control
What the company is doing
An URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated 8/6/24 was sent to customers. Actions Required by B. Braun Medical Inc. (BBMI) Customer/User: 1. Review the Medical Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons are informed about this voluntary recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the consumer level. 2. Determine your current inventory of the affected items within inventory of your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached "Medical Device Recall Acknowledgement Form", record the total number of individual impacted units. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed "Medical Device Recall Acknowledgement Form" to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your Medical Device Recall Acknowledgement Form, a B. Braun Customer Support representative will contact you with instructions on how to return any impacted cases, including partial cases, in your possession and provide credit and/or replacement of the product based on your individual needs. Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to BBMl's Postmarket Surveillance Department by calling 1-844-903-6417. They may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Recall details
- Recall number
- Z-3144-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 8, 2024
- Posted by the FDA
- Sep 13, 2024
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 19050 units
- Product code
- FPA
- FDA submissions
- K111016, K022895, K943770
- Distribution
- US Nationwide distribution.
Product description
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
Code information (models, lots, serial numbers)
Model No 472036; UDI-DI 04046964184659; Lots 0061898815, 0061905158, 00VL872690, 00VL882317 and 00VL882319
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Extension Set 472036B. Braun Medical Inc. · Set, administration, intravascular1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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