FDA Medical Device Recalls (openFDA)
Somatex Medical Technologies GmbH: TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
- Recall number
- Z-0410-2018
- Recalling firm
- Somatex Medical Technologies GmbH
- Product
- TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
- Status
- Terminated
- Initiated
- 2017-05-22
- Posted
- not on file
- Terminated
- 2018-08-30
- Reason
- There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.
- Root cause
- Device Design
- Action
- On May 22, 2017, Somatex Medical Technologies distributed notices to their customers advising them of the reason for recall. Customers are advised to inspect stock, quarantine and not use affected product. Products will be exchanged free of charge and a replacement delivery will be arranged promptly. All customers are expected to complete and return the response form via fax.
- Quantity
- not on file
- Distribution
- NY - Only one US distributor
- Lot, serial or model codes
- Lot numbers: 47883, 47910 & 47911
- 510(k) numbers
- ["K073095"]
- PMA numbers
- not on file
- Product code
- NEU
- Firm FEI
- 1000408433
- Firm city
- Teltow
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28