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Soosung Elastic Bandage
soosung medical · Model 3" · UDI-DI 08809302587224
10
510(k) clearances
297
Adverse events
30
Recalls
698
Facilities
Description
an elastic bandage woven from cotton yarn and threaded rubber or cotton yarn Surgical treatment and protection and preservation of affected areas
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-27 | Medline Industries, LP | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. |
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2024-04-02 | Andover Healthcare Inc. | A packaging seal gap could impact the sterility of the product. |
| 2022-06-22 | ASO LLC | The product falls apart during handling after removal from its primary packaging. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2022-02-01 | BSN Medical Inc | The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled. |
| 2020-08-21 | North American Rescue LLC. | Lack of sterility assurance of the 30-0171 |
| 2019-06-19 | Andover Healthcare Inc. | Incomplete packaging seal of sterile product |
| 2019-06-19 | Andover Healthcare Inc. | Incomplete packaging seal of sterile product |
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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.