18 Gauge thin wall needle as part of a Central Venous Catheter Kit
FDA Recall Z-0543-04 · Posted 2004-02-24
Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeFOZ
Date Initiated2003-12-17
Date Terminated2004-07-27
Product Quantity93564
Reason for Recall
18 gauge needles in Central Venous Catheter kits may be partially occluded.
Firm Action
Consignees were notified by FedEx letter on 12/17/2003.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.