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Terminated

Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE brand. Manufactured for Medline Industries, Inc. Mundelein, IL 60060 USA Made in USA MEDLINE in a registered trademark of Medline Industries, Inc. 1-800-MEDLINE.

FDA Recall Z-0069-2010 · Posted 2009-10-21

Recalling FirmUnimed Surgical Products, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2009-08-28
Date Terminated2010-05-12
Product Quantity1920 units

Reason for Recall

Unimed Surgical Products, Inc., Largo, FL initiated a voluntary recall of the Extended PTFE Coated Blade electrosurgical electrodes, product number ES0014, due to concerns regarding product sterility for Lot #042209-03.

Firm Action

Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated August 28, 2009. The customer, Medline Industries, Inc., was instructed to quarantine any undistributed product and to notify its customers of the recall. For further information, contact Unimed Surgical Products, Inc. at 1-727-546-1900 or 1-800-886-1225.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution -- MI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962935UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODEUnimed Surgical Products, Inc. · 1996-09-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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