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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 December 12, 2011
Date Posted January 26, 2012
Recall Status1 Terminated 3 on August 29, 2016
Recall Number Z-0871-2012
Recall Event ID 60823
Product Classification General surgery tray (kit) - Product Code LRO
Product Presource Custom Sterile Surgical and Procedure Kits; general surgery 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:

a) Silastic Tubing, 0.062 ID x 0.032 Wall x 50 Ft, component C-602-285, vendor part number SFM3-2850;
b) Silastic Tubing, 0.040 ID x 0.023 Wall x 50 Ft, component C-SFM3-2050, vendor part number SFM3-2050;
c) Pathology Container with Lid, 8 oz., component 3701Z, vendor part number 3701;
d) Silicone Tubing, 0.187 ID x 0.313 OD x 50 Ft., component C-31010SG, vendor part number 31010;


Code Information all recent lots of the following kit catalog numbers PBVFLCAVJ, PCW1VPMUW, PE41TP55A, PE73EALUO, PE73MNLUM, PEDKEASTH, PEOCMEBL1, PEOCMEBLD, PEVFBHAVK, PEVFENAVH, PEVFHNAVJ, PEVNMJCHF, PG73HNLUL, PG73OTALUN, PGCGOTUI8, PGCGOTUII, PGVFGMAVM, PGVFLPAVC, PGVFMNAVG, PGVFOTAVD, PGVFTTAVK, PGVNGSCHJ, PLVFOTAVJ, PN21CYBIG, PN21CYBIH, PN41CY557, PN73CR11F, PN73SPLUT, PN73VPLUV, PNV2ALCPA, PNV2CY10Z, PNV2LM10R, PNV2OT10H, PNV2OTA10Q, PNVFLNAVK, PO73AALU1, PO73AALUR, PP69OHMLO, PUOCOT13J, PVV2CA10B, SBA13KDBSY, SBA23KTNCC, SBA23OPNCC, SBACGSTAHA, SCV11CACPR, SCV19OHCHX, SCV23MJNCH, SEN41TYCMC, SID21ACUHA, SIDCGISAUA, SNE11ALCPA, SNE11CR10F, SNE11LM10C, SNE11NMCPX, SNE14ACHHK, SNE14CRHHK, SNE14LLHHN, SNE21SHEGS, and SNE32CRSA7. 
Recalling Firm/
Manufacturer
Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information Contact Michele B. Donatich R.N.
847-473-1500
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
PMA
Action 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.
Quantity in Commerce 7,213 each
Distribution Nationwide Distribution -- California, Georgia, Illinois, Massachusetts, Michigan, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.
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.
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