Recall Z-2131-2024 ยท BXN Stimulator, Nerve, Battery-Powered
B Braun Medical Inc
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
| Date | Jun 11, 2024 (initiated May 17, 2024) |
| Status | Open, Classified |
| Reason | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 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 distribut |
| Quantity | 20,850 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K860126 | STIMUPLEX, NERVE STIMULATOR Burron Medical Products, Inc., Feb 28, 1986 |