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U.S. Department of Health and Human Services

Class 2 Device Recall Stimuplex

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 Class 2 Device Recall Stimuplexsee related information
Date Initiated by FirmMay 17, 2024
Date PostedJune 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2131-2024
Recall Event ID 94637
510(K)NumberK860126 
Product Classification Stimulator, nerve, battery-powered - Product Code BXN
ProductStimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
Code Information Catalogue Number: 4894251; UDI/DI: 04022495101167; Lot/Batch: 20E15, 19L09, 19L27, 20A19, 20H21, 21G14, 21I16, 22H23.
Recalling Firm/
Manufacturer		 B Braun Medical Inc
200 Boulder Dr
Breinigsville PA 18031-1532
For Additional Information ContactPost Market Surveillance Department
833-425-1464
Manufacturer Reason
for Recall		The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
FDA Determined
Cause 2		Component design/selection
ActionOn 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 recalls@bbraunusa.com 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 Commerce20,850 units
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BXN
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