Z-2133-2024Class II

Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278

Name: Z-2133-2024 Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
Creator: B Braun Medical Inc
Published: 2024-05-17
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2024-05-17 / Open, Classified / root cause: design

FDA source

B Braun Medical Inc began a recall of Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278 on 2024-05-17. FDA classified it as Class II and gives the reason as "The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2133-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-17
Posted: 2024-06-11
Recalling firm: B Braun Medical Inc
Product: Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
Product code: BXN Stimulator, Nerve, Battery-Powered
Reason for recall: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Root cause tag: design
FDA root cause: Component design/selection
Action: On May 17, 2024, URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Actions Required by B. Braun Medical Inc. (BBMI) Customer/User: 1. Review this notice in its entirety. Ensure that all users in your organization of the above-mentioned products, and other concerned personnel are informed about this voluntary correction. Post this notification where the affected products are stored. a. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The correction is to be extended to the consumer level. b. If you are a distributor that distributes partial cases, please ensure a copy of this notice is forwarded to your consignees. 2. Determine your current inventory. Review your inventory frequently to check these lot numbers. 3. Return the completed Urgent Medical Device Correction 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). For questions regarding the label and impacted Stimuplex A Needles, please call Customer Support at 1-800-227-2862. Adverse reactions or quality problems experienced with this product, or questions about this correction may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464. Adverse Reactions or quality problems in the United Sates may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 108,811 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: Catalogue Number: 4894278; UDI/DI: 04022495101266; Lot/Batch: 20E15, 21E18, 19F08, 19G10, 19G13, 19G19, 19I19, 20C28, 20C31, 20D10, 20L19, 21B13, 21I17, 21K21, 21L12, 21M16, 22D12, 22H20, 22I22, 22K27, 23A20, 23C04, 23D14, 23F09, 23I08, 23I29.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2133-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2131-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-11
Z-2132-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-11
Z-2133-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-11
Z-2134-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-11

Product code BXN

K860126Class IIStimuplex, Nerve StimulatorBurron Medical Products, Inc. / cleared 1986-02-28

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)