1000 ml Canister — Class II medical device recall Z-2171-2017
Terminated recall by KCI USA, INC., reported 2017-06-07, distributed nationwide. Potential sterile barrier breach
| Recall number | Z-2171-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KCI USA, INC., San Antonio, TX, United States |
| Recall initiated | 2017-04-28 |
| Classified | 2017-05-30 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2018-02-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, DO, EC, EE, GT, JP, MX, MY, PA |
| Quantity | 5,385 cases |
| Reason classes | sterility |
| Model numbers | M8275093/5 |
Product
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. All exudates and infectious materials are collected in the canister
Reason for recall
Potential sterile barrier breach
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.