FDA Device recall Z-0410-2018
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
- FDA Device
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE by Somatex Medical Technologies, citing there is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0410-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-22 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Somatex Medical Technologies |
| Distribution | NY |
Product
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
Reason
There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.
Identifiers
| code_info | Lot numbers: 47883, 47910 & 47911 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0410-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.