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U.S. Department of Health and Human Services

Class 2 Device Recall Presource Custom Sterile Surgical and Procedure Kits

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  Class 2 Device Recall Presource Custom Sterile Surgical and Procedure Kits see related information
Date Initiated by Firm September 03, 2011
Date Posted October 31, 2011
Recall Status1 Terminated 3 on August 01, 2016
Recall Number Z-0141-2012
Recall Event ID 59909
Product Classification Tray, surgical - Product Code LRP
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) Split Dressing - 2"x 2", Yellow, component C-033-0022, vendor part number S1072;
b) Tubing Extension Sets and IV Sets
component C-FG711297CP, vendor pn FG711297CP;
component C-FG711093CP, vendor pn FG711093CP;
component C-FG711298CP, vendor pn FG711298CP;
component C-FG711092CP, vendor pn FG711092CP;
c) Cast Padding
component C-9046, vendor pn 9046;
component C-9044, vendor pn 9044;
component C-9043, vendor pn 9043;
component C-9062, vendor pn 9062;
d) Scalpel Holder
component C-DD1628-6, vendor pn DD1628-6;
e) Latex Tubing
component C-806-12, vendor pn 806-12;
component C-808R, vendor pn 808R;
component C-606R, vendor pn 606R;
component C-122BA10, vendor pn 122BA10;
component C-122BA12, vendor pn 122BA12;
component C-122BA07, vendor pn 122BA07;
component C-102BA12, vendor pn 102BA12;
component C-099BA10, vendor pn 099BA10;
component C-102BA10, vendor pn 102BA10;
component C-103BA10, vendor pn 103BA10;
component C-124BA10, vendor pn 124BA10;
component C-140BA10, vendor pn 140BA10;
f) Clinic Dropper
component C-12548, vendor pn 10-871-00;
g) Tongue Blade (depressor)
component C-11820-010, vendor pn 07-920-00;
h) Catheter Clamp
component C-043-0497, vendor pn 033403-887;
i) Gillette Good News Razor
component C-P4417A, vendor pn 4417GN;
j) Prepsicle Round Short Blue Swabstick
component C-051-0401, vendor pn SBR20035;
k) Tubing
component C-SFM3-3050, vendor pn SFM3-3050;
component C-SFM3-3650, vendor pn SFM3-3650;
l) Specimen Container
component C-B9021YN, vendor pn B9021YN;
component C-C8846-18, vendor pn 15706-806;

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.
Code Information all recent lot numbers of the following kit catalog numbers 03-0271, 03-0692A, 03-4563C, 05-0102, 09-5197F, 12-0088, 12-5210U, 12-5596, 13-0426E, 13-0879, 13-1527B, 17-2701B, 23626-640, 23626-660, 24012-060, 24012-360, 5C4150A, CFISP3EDTA, CFISPDHCBA, CS9044 and CS9046
Recalling Firm/
Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information Contact Michele B. Donatich R.N.
Manufacturer 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.
FDA Determined
Cause 2
Component design/selection
Action 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.
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.