FDA Device recall Z-2050-2017
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal…
- FDA Device
- Class II
- terminated
- Published 2017-05-17
On 2017-05-17 the FDA classified a Class II recall of Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal… by Mederi Therapeutics, citing product sterility compromised due to breach in sterile barrier package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2050-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-03 |
| Published | 2017-05-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mederi Therapeutics |
| Distribution | US |
Product
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
Reason
Product sterility compromised due to breach in sterile barrier package
Identifiers
| code_info | Lot Numbers: 291ST-16 102ST-16 102ST-16R-1 102ST-16R-2 116ST-16R 116ST-16R2 116ST-16R3 116ST-16R4 139ST-16 1…Lot Numbers: 291ST-16 102ST-16 102ST-16R-1 102ST-16R-2 116ST-16R 116ST-16R2 116ST-16R3 116ST-16R4 139ST-16 139ST-16-1 139ST-16-2 139ST-16-3 144ST-16 209ST-16 227ST-16 243ST-16 276ST-15 286ST-16 290ST-16 291ST-16 299ST-16 306ST-16 310ST-15 |
|---|
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-2050-2017%22
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