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

Recall Z-2442-2012 — Sleek OTW Ref 426-1501XInflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150Lot 500266882013-09CordisPTA Dilatation CatheterCordisJohnson Johnson CompanySterileEOMethod of Sterilization: ETOClearStream***Clearstream Technolo

U.S. FDA — Device Enforcement · United States · 2011-01-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2442-2012
Date of alert: 2011-01-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cordis Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 50026688

Reported risk: On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled.

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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