Z-0871-2012

Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL...

Name: Z-0871-2012 Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL...
Creator: Cardinal Health
Published: 2011-12-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-12-12 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health began a recall of Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code... on 2011-12-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0871-2012
Status: Terminated
Initiated: 2011-12-12
Posted: 2012-01-26
Terminated: 2016-08-29
Recalling firm: Medtronic, Inc.
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;
Product code: LRO General Surgery Tray
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)