Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
FDA Recall Z-3107-2017 · Posted 2017-08-14
Recalling FirmCardinal Health 200, LLC
Recall StatusTerminated
Product CodeLRO
Date Initiated2017-08-01
Date Terminated2019-06-18
Product Quantity184,102 kits
Reason for Recall
The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
Firm Action
BD sent an Urgent Medical Device Recall letter dated June 12, 2017, to all affected customers. The firm requested the consignee cease use and segregate the products, complete and return the response form. Distributors were requested to notify their customers of the action. Customers with questions were instructed to call 201-847-4267. For questions regarding this recall call 800-292-9332.
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution - US (Nationwide) and Internationally to Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.