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

FDA device recall Z-0170-2012 · posted 2011-11-07 · 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 manufacturers do not have all necessary FDA registrations or filings needed for these components.

Action taken

Cardinal Health issued an URGENT: PRODUCT RECALL letter dated September 30, 2011 to the affected wholesale 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 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 Distributor Management Group at 800-635-6021. This wholesale recall was expanded to include additional kits via letter dated October 5, 2011, with the same instructions as listed above. For questions regarding this recall call 800-292-9332.

Root cause

Component design/selection

Status

Terminated

Product code

LRP

Distribution

Nationwide Distribution including California, Florida, Illinois, Kentucky, Minnesota, Missouri, Ohio, Tennessee, Washington, West Virginia and Wisconsin

Date initiated

2011-09-30

Date posted

2011-11-07

Date terminated

2016-08-01

Location

Park, IL