Cardinal Health: Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C Act: a) Adhesive Remover Wipes, component 050-0415; b) Perineze Perineal Witch Hazel Pad, component 505040A c) 24" Infant Tape Measure, component 30942P; d) Triple Dye Drug, 10 unit dose, component PM1022; The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

Recall number

Z-0170-2012

Recalling firm

Cardinal Health

Product

Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C Act: a) Adhesive Remover Wipes, component 050-0415; b) Perineze Perineal Witch Hazel Pad, component 505040A c) 24" Infant Tape Measure, component 30942P; d) Triple Dye Drug, 10 unit dose, component PM1022; The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

Status

Terminated

Initiated

2011-09-30

Posted

2011-11-07

Terminated

2016-08-01

Reason

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.

Root cause

Component design/selection

Action

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.

Quantity

not on file

Distribution

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

Lot, serial or model codes

all recent lots of the following kit catalog numbers 03-2503F 03-2503H, 03B5615C, 4628, BA3CG4740K, BAB239109A, BAB920079C, MA1567670P, MA2CG6972D, MAN21ATAMC, MAT453740O and MATW11527D

510(k) numbers

not on file

PMA numbers

not on file

Product code

LRP

Firm FEI

3001236905

Firm city

Park

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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