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

Recall Z-1532-2024 — Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20- COONS G0392

U.S. FDA — Device Enforcement · United States · 2024-03-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1532-2024
Date of alert: 2024-03-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cook Incorporated
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00827002039285

Reported risk: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

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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