Somatex TUMARK Q Medical Device Recalled for Sterility Risk
Somatex Medical Technologies is recalling TUMARK Q devices due to a potential risk of packaging puncture that could compromise sterility.
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 risk-of-harm product (loss of sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Somatex Medical Technologies GmbH is recalling specific lots of TUMARK Q medical devices. The affected products are sterile, 12 cm in length, 18G in diameter, and identified by GTIN 04250195603081 and REF 271500. The recall involves lot numbers 47883, 47910, and 47911.
The recall is being issued because there is a potential risk of puncture to the packaging material. This defect can compromise the sterility of the devices, rendering them non-sterile. The agency classification for this recall is Class II.
The distribution pattern indicates that the products were distributed only to one US distributor in New York. Consumers and healthcare providers should stop using the affected devices and contact the recalling firm for further instructions.
The recalled product
- Product
- TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
- Manufacturer
- Somatex Medical Technologies GmbH
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 numbers: 47883
- 47910 & 47911
Distribution
Distribution scope not specified by the agency.
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