Z-0543-04

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

Name: Z-0543-04 18 Gauge thin wall needle as part of a Central Venous Catheter Kit
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-12-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-12-17 / Terminated

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of 18 Gauge thin wall needle as part of a Central Venous Catheter Kit on 2003-12-17. The reason FDA records is "18 gauge needles in Central Venous Catheter kits may be partially occluded". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0543-04
Status: Terminated
Initiated: 2003-12-17
Posted: 2004-02-24
Terminated: 2004-07-27
Recalling firm: Abbott Medical
Product: 18 Gauge thin wall needle as part of a Central Venous Catheter Kit
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: 18 gauge needles in Central Venous Catheter kits may be partially occluded.
FDA root cause: Other
Action: Consignees were notified by FedEx letter on 12/17/2003.
Quantity in commerce: 93564
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.
Product codes and lots: 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.

Product code FOZ

K961552Class IICvp Polyurethane CatheterAbbott Laboratories / cleared 1997-02-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)