Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The

FDA device recall Z-0925-2012 · posted 2012-01-27 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

The Presource kits were assembled with a Jobri Infant Restraint Strap which does not have the appropriate 510(k) pre-market clearance.

Action taken

Cardinal Health issued an URGENT: PRODUCT RECALL letter dated December 23, 2011 to the affected hospital consignees via UPS next day air. The letter identified the product, problem, and actions to be taken. Enclosed with the letter were recall labels, instructing the customer not to use the affected component upon opening the kit, to affix recall label to the front side of each affected Presource kit and shipping carton currently in their inventory. The customers were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules labeled. For component credit/replacement the consignees were instructed to contact the folowing: Hospitals - Presource Sales Operations at 800-766-0706; Federal Government facilities - Government Customer Service at 800-444-1166; and Distributors - Distributor Management Group at 800-635-6021. For any questions, require additional labels or desire special assistance relating to this recall contact Cardinal Health Quality Systems, 800-292-9332.

Root cause

No Marketing Application

Status

Terminated

Product code

LRO

Quantity affected

15,369 kits in total

Distribution

Nationwide Distribution (USA) including the states of: Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Maryland, Missouri, North Carolina, Nebraska, N

Date initiated

2011-12-23

Date posted

2012-01-27

Date terminated

2016-08-01

Location

Park, IL