Trumpet Needle Guide Ring May Detach Under Excessive Pressure
Technicality Inc. is recalling Trumpet Needle Guides (Cat# TMS-200) because the ring can detach when excessive pressure is applied. Approximately 20,000 units distributed nationwide in Illinois are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with a potential risk-of-harm from component detachment, but no reported injuries or illnesses in the source. Per the rubric, risk-of-harm products without reported injury fall under the High (3) category.
Plain-English summary
Technicality Inc. is recalling the Trumpet Needle Guide (Cat# TMS-200). Approximately 20,000 units are subject to this Class II recall.
The ring on the needle guide can detach when excessive pressure is applied.
The recalled units were distributed nationwide in the state of Illinois. Affected lot numbers are 22190 and 22497.
The recalled product
- Product
- Trumpet, Needle Guide, Cat# TMS-200
- Manufacturer
- Technicality Inc.
- Category
- Medical Device — Needle Guide
- Hazard
- Affected units
- 20,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 22190 & 22497
Distribution
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