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

Recall Z-2288-2012 — Product is labeled in part: "MEDLINEExtended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) LengthReorder: ES0016AMContents: 1 EachSINGLE USE ONLYlatexfreeRX Only*STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered tradem

U.S. FDA — Device Enforcement · United States · 2010-06-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2288-2012
Date of alert: 2010-06-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Unimed Surgical Products, Inc.
Product category: device
Product type: Devices

Reported risk: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of 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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