Recall Z-0777-2024 ยท MUI Media, Coupling, Ultrasound
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
| Date | Jan 20, 2024 (initiated Jun 9, 2023) |
| Status | Open, Classified |
| Reason | Sterility of Ultrasound gel can not be guaranteed. |
| Root cause | Nonconforming Material/Component |
| Action | 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 . |
| Quantity | 4,923,471 |
| Distribution | US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130581 | KONIX STERILE GEL Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa, Jun 18, 2014 |