18 Gauge thin wall needle as part of a Central Venous Catheter Kit
This recall has been terminated (originally issued February 24, 2004).
- 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
- Official Source
- View on FDA website ↗
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.