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AMSure®Sterile Water for Wound Flush
AMSINO INTERNATIONAL, INC. · Model 1 · UDI-DI 00704411010367
1
510(k) clearances
3,144
Adverse events (63 deaths)
82
Recalls
383
Facilities
Description
AMSure® Sterile Water for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water for wound flush are intended to be used in home care and should only be used by clinicians familiar with the treatment of possible complications.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-08 | ConvaTec, Inc | Surgical dressing manufactured out of specification (greater thickness). |
| 2026-04-27 | Oculus Technologies of Mexico, S.A. de C.V. | The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the produc |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-05 | Medline Industries, LP | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for |
| 2026-01-05 | Medline Industries, LP | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
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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.