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

Recall Z-2480-2018 — Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Re

U.S. FDA — Device Enforcement · United States · 2018-02-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2480-2018
Date of alert: 2018-02-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cardinal Health 200, LLC
Product category: device
Product type: Devices

Reported risk: A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.

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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