MEDLINE INDUSTRIES, LP – Northfield Recall 92466
Description: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSERTION BUNDLE, Model Number DT21275; c) VA MAINTENANCE PACK, Model Number EBSI1382; d) MIDLINE DRESSING CHANGE KIT, Model Number EBSI1464;
MEDLINE INDUSTRIES, LP – Northfield Recall 92466 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2202-2023 |
| Event ID | 92466 |
| Event Description | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSERTION BUNDLE, Model Number DT21275; c) VA MAINTENANCE PACK, Model Number EBSI1382; d) MIDLINE DRESSING CHANGE KIT, Model Number EBSI1464; |
| 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 | 572 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 CVI4770A, UDI/DI (EA) 10653160350828, UDI/DI (CS) 00653160350821; b) Model Number DT21275, UDI/DI (EA) 10653160318934, UDI/DI (CS) 00653160318937; c) Model Number EBSI1382, UDI/DI (EA) 10193489196269, UDI/DI (CS) 20193489196266; d) Model Number EBSI1464, UDI/DI (EA) 10193489198959, UDI/DI (CS) 20193489198956; |
| Center Classification Date | 20230720 |
| Recall Initiation Date | 20230518 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Initial Notification | Letter |
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