Recall Z-2290-2023 ยท MMP Cover, Barrier, Protective
MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Number DYNJE5920; d. COVER, PROBE, W/GEL AND BANDS, 6X96 - Model Number DYNJE5930; e. COVER, PROBE, W/GEL AND BANDS, 5X48 - Mod
| Date | Aug 3, 2023 (initiated May 15, 2023) |
| Status | Open, Classified |
| Reason | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| Root cause | Nonconforming Material/Component |
| Action | Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the ki |
| Quantity | 1,231,480 kits |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates. |
| FDA record | Open on fda.gov |