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

FDA device recall Z-0871-2012 · posted 2012-01-26 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturer(s) does not have all necessary FDA registrations or filings needed for this product.

Action taken

Cardinal Health issued an URGENT: PRODUCT RECALL letter dated December 12, 2011 to the affected hospital consignees via UPS next day air. The letter informed them that their Presource kits listed in the attached spreadsheet contain various components also listed on the attachment that are being recalled because the component manufacturer(s) do not have all the necessary FDA registrations or filings needed for these components. Enclosed with the letter were recall labels, instructing the user not to use the affected component upon opening the kit, to be affixed to the front side of each affected Presource kit and shipping carton in their inventory. The labels have an ID code which coincides with the code on the component attachment to the letter. The accounts 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, the consignees were instructed to contact Presource Sales Operations at 800-766-0706.

Root cause

PMA

Status

Terminated

Product code

LRO

Quantity affected

7,213 each

Distribution

Nationwide Distribution -- California, Georgia, Illinois, Massachusetts, Michigan, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.

Date initiated

2011-12-12

Date posted

2012-01-26

Date terminated

2016-08-29

Location

Park, IL