Recall Z-1460-2024 ยท MDM Instrument, Manual, Surgical, General Use
Technicality Inc.
Trumpet, Needle Guide, Cat# TMS-200
| Date | Apr 2, 2024 (initiated Jan 31, 2024) |
| Status | Open, Classified |
| Reason | The Ring on the Trump Needle Guide can detach when excessive pressure is applied. |
| Root cause | Process control |
| Action | Technicality Medical Supplies, Inc. issued a Urgent Field Safety Notice to its sole consignee via email on 01/31/2024. The notice explained the problem with the device and requested the consignee quarantine any affected product in inventory and contact their customers. |
| Quantity | 20000 units |
| Distribution | US Nationwide distribution in the state of Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.