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ProCure
Twin Med, LLC · Model PCAB200 · UDI-DI 10840330701065
10
510(k) clearances
297
Adverse events
30
Recalls
698
Facilities
Description
Bandages Elastic w/Velcro Self-Closure 2"x 5yds Latex Free - 10ea/bx 5bx/cs
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.