FDA Recalls Defective Ultrasound Needles That May Leak at Hub
RM Temena GmbH is recalling 7,370 ultrasound needles that may leak at the needle hub. The defective needles were distributed in Maryland and Illinois.
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: The recall involves a medical device defect that poses a risk of harm (leaking) but does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
RM Temena GmbH is recalling 7,370 ultrasound needles, 22G (0.7 mm) x 50mm, item number REF USC050-22. These needles are used for peripheral nerve blocking under ultrasound guidance. The recall is due to a defect where the needles may leak at the needle hub.
The affected needles are identified by Lot B3170005 with an expiration date of 2018-05-31. They were distributed in the United States, specifically in the states of Maryland and Illinois.
Consumers and healthcare providers should stop using these needles and contact the manufacturer for further instructions.
The recalled product
- Product
- Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
- Manufacturer
- RM Temena GmbH
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 7,370
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 (2)
- Lot B3170005
- EXP 2018-05-31
Distribution
Part of a larger recall action
This product is one of 2 recalled by RM Temena GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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See all →- HighFDA Recalls Defective Ultrasound Needles That May Leak at Hub
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