Tumark Q recall: Sterility Concern
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
Why was Tumark Q recalled?
There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: 47883, 47910 & 47911
- Product
- TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
- Recalling firm
- Somatex Medical Technologies GmbH
- Quantity
- N/A
- Distribution
- NY - Only one US distributor
- Recall date
- January 31, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)