Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use duri
FDA device recall Z-2154-2023 · posted 2023-07-20 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- Action taken
- Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- MMP
- Quantity affected
- 1,505,262 kits
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
- Date initiated
- 2023-05-18
- Date posted
- 2023-07-20
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDLINE BAND BAGS AND EQUIPMENT COVERS (K032065) | Medline Industries, Inc. | 2003-09-22 |