REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
FDA device recall Z-0777-2024 · posted 2024-01-20 · Open, Classified
Recall details
- Recalling firm
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
- Reason for recall
- Sterility of Ultrasound gel can not be guaranteed.
- Action taken
- On June 5, 2023, Turkuaz issued a "Field Safety Notice to affected consignee(s). On December 13, 2023, an updated notification was provided to affected consignee(s) Turkuaz asked consignees to return the recalled items or destroy them. If you have any questions, email the Quality Director at secil.pala@turkuazsaglik.com.tr .
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- MUI
- Quantity affected
- 4,923,471
- Distribution
- US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
- Date initiated
- 2023-06-09
- Date posted
- 2024-01-20
- Location
- Esenyurt, Turkey
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KONIX STERILE GEL (K130581) | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2014-06-18 |