MEDLINE INDUSTRIES, LP – Northfield Recall 92466
Description: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model Number TVS4000K
MEDLINE INDUSTRIES, LP – Northfield Recall 92466 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2176-2023 |
| Event ID | 92466 |
| Event Description | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model Number TVS4000K |
| Product Type | Devices |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia. |
| Quantity | 4644 units |
| Recall Reason | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| Device Classification | 20230726 |
| Device Code Info | all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ46967F, UDI/DI (EA) 10193489576047UDI/DI (CS) 40193489576048; b) Model Number DYNJ62557, UDI/DI (EA) 10193489669152UDI/DI (CS) 40193489669153; c) Model Number DYNJ81973, UDI/DI (EA) 10195327204877UDI/DI (CS) 40195327204878; d) Model Number TVS4000K, UDI/DI (EA) 10816982023862UDI/DI (CS) 40816982023863; |
| Center Classification Date | 20230720 |
| Recall Initiation Date | 20230518 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Initial Notification | Letter |
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