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Terminated

Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1

FDA Recall Z-0563-05 · Posted 2005-02-25

Recalling FirmTissueLink Medical, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2005-02-07
Date Terminated2005-04-20
Product Quantity588 units

Reason for Recall

The tip may separate from the device and render it unusable

Firm Action

TissueLink notified consignees by Federal Express Letter from 2/7/05 to 2/8/05. Users are requested to return devices in inventory.

Root Cause

Other

Distribution Pattern

AZ, CA, CO, CT, DE, IL, FL, KS, KY, OH, MA, MD MO,NC, NY, PA, RI, SC, TN,TX, VA Foreign: Italy, Turkey, Egypt, Spain, Peru, Portugal, Australia, Netherlands Government: VA Medical Center 508 Fulton Street Durham, NC 27005 VA Medical Center- 7400 Merton Minter Blvd San Antonio, TX 78229 VA Medical Center- Pittsburgh University C Pittsburgh, PA 15240

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K014260TISSUELINK SOLID CYLINDER MONOPOLAR DEVICETissuelink Medical, Inc. · 2002-03-27

Official Source

View FDA Recall →

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

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