Z-3144-2024Class II

AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock...

Name: Z-3144-2024 AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock...
Creator: B. Braun Medical, Inc.
Published: 2024-08-08
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2024-08-08 / Open, Classified

FDA source

B. Braun Medical, Inc. began a recall of AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036 on 2024-08-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3144-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-08
Posted: 2024-09-13
Recalling firm: B Braun Medical Inc
Product: AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
Product code: FPA Set, Administration, Intravascular
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.
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 19050 units
Distribution: US Nationwide distribution.
Product codes and lots: Model No 472036; UDI-DI 04046964184659; Lots 0061898815, 0061905158, 00VL872690, 00VL882317 and 00VL882319

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3144-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3144-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-13

Product code FPA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)