Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific di

FDA device recall Z-3107-2017 · posted 2017-08-14 · Terminated

Recall details

Recalling firm

Cardinal Health 200, LLC

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.

Action taken

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

Status

Terminated

Product code

LRO

Quantity affected

184,102 kits

Distribution

Worldwide Distribution - US (Nationwide) and Internationally to Canada

Date initiated

2017-08-01

Date posted

2017-08-14

Date terminated

2019-06-18

Location

Waukegan, IL