FDA Recall
Open, Classified
Trumpet, Needle Guide, Cat# TMS-200
Recall: Z-1460-2024
·
Initiated January 31, 2024
Recall
- Recall Number
- Z-1460-2024
- Event Number
- 94135
- Firm
- Technicality Inc.
- FEI Number
- 1450901
- Product Code
- MDM
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- January 31, 2024
- Posted
- April 2, 2024
- Address
- 661 S Addison Rd, Addison, IL, 60101-4648
Description
Trumpet, Needle Guide, Cat# TMS-200
Reason
The Ring on the Trump Needle Guide can detach when excessive pressure is applied.
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.
Distribution
US Nationwide distribution in the state of Illinois.
Quantity
20000 units