RecallDepth

18 Gauge thin wall needle as part of a Central Venous Catheter Kit

Company
Abbott Laboratories Hpd/Add/Gprd
Recall Initiated
December 17, 2003
Posted
February 24, 2004
Terminated
July 27, 2004
Recall Number
Z-0543-04
Quantity
93564
Firm Location
Abbott Park, IL

Reason for Recall

18 gauge needles in Central Venous Catheter kits may be partially occluded.

Distribution

Nationwide including VA facilities in ID and NC. Foreign distribution to Australia, Austria, Belgium, Brazil, Canada, Chile, Columbia, Dominican Republic, Egypt, Greece, Ireland, Italy, Japan, Malaysia, Portugal, Slovenia, Spain, Switzerland, Turkey, UK, United Arab Emirates.

Lot / Code Info

List No. 414000413, Lot No. 02053SN, 02062SN, 03307SN, 04064SN, 05248SN, 05308SN, 06248SN, 93297SN, 96294SN. List No. 414000415, Lot No. 04240SN, 04241SN. List No. 414010423, Lot No. 02057SN, 02065SN, 03257SN, 04238SN, 05341SN, 06249SN, 93208SN, 94194SN, 95224SN, 96054SN. List No. 414010425, Lot No. 02051SN, 02058SN. List No. 414050415, Lot No. 04239SN, 06244SN, 07244SN, 95221SN. List No. 414060423, Lot No. 02059SN, 03261SN, 06245SN, 93206SN, 95220SN, 95232SN. List No. 414070423, Lot No. 02354SN, 03258SN, 95222SN. List No. 414110423, Lot No. 02052SN, 03259SN, 05342SN, 07250SN, 93296SN, 94196SN, 95233SN. List No. 414110425, Lot No. 02049SAN, 03260SAN, 93207SN. List No. 414130415, Lot No. 02050SN, 04065SN, 05249SN, 95223SN, 95229SN. List No. 414140423, Lot No. 02061SN, 04063SN, 06247SN, 94195SN, 95231SN, 96056SN.

Root Cause

Other

Action Taken

Consignees were notified by FedEx letter on 12/17/2003.

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