Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2134-2017 — Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque sec

U.S. FDA — Device Enforcement · United States · 2017-04-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2134-2017
Date of alert: 2017-04-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cardinal Health 200, LLC
Product category: device
Product type: Devices

Reported risk: Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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