Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit cat

FDA device recall Z-0141-2012 · posted 2011-10-31 · 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 September 2, 2011 to all affected consignees via UPS next day air, informing them that their Presource kits listed in the attached spreadsheet contain various components listed on the attachment, which 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 to affix to the front side of each affected Presource kit in their inventory. The labels have an ID code which coincides with the code on the component attachment to the letter. If the consignee does not wish to accept overlabeled product or to overlabel the product in their possession, they were asked to contact Presource Sales Operations at 800-766-0706 or their Sales Representative for further instructions. 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 the following: Hospitals - Presource Sales Operations at 800-766-0706, Distributors - Distributor Management Group at 800-635-6021, and Federal Government facilities - Government Service at 800-444-1186. For questions regarding this recall call 847-887-6412.

Root cause

Component design/selection

Status

Terminated

Product code

LRP

Distribution

Nationwide Distribution

Date initiated

2011-09-03

Date posted

2011-10-31

Date terminated

2016-08-01

Location

Park, IL