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Alleset
GRI Medical & Electronic Technology Co., Ltd. · Model 80-05814G · UDI-DI 16931918123783
0
510(k) clearances
361
Adverse events
41
Recalls
399
Facilities
Description
Top Drape_276x150cm_TRI-LAMINATE MATERIAL_Non-sterial_26EA/CS
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-28 | Medline Industries, LP | Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in p |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag |
| 2025-04-13 | Microtek Medical, Inc. | Due to non-sterile products being labeled as sterile |
| 2025-02-13 | MEDLINE INDUSTRIES, LP - Northfield | Potential breach in pouch packaging which could lead to loss of sterility. |
| 2023-06-23 | Microtek Medical Inc. | Certain lots of the products have a Naphthalene odor. |
| 2022-10-06 | 3M Healthcare Business | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the produc |
| 2022-10-06 | 3M Healthcare Business | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the produc |
| 2022-10-06 | 3M Healthcare Business | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the produc |
| 2022-10-06 | 3M Healthcare Business | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the produc |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.