Z-1194-2013Class I

A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit

Name: Z-1194-2013 A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit
Creator: Cardinal Health, Medical Products & Services
Published: 2013-03-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-03-26 / Terminated / root cause: packaging

FDA source

Cardinal Health, Medical Products & Services began a recall of A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit on 2013-03-26. FDA classified it as Class I and gives the reason as "Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1194-2013
Classification: Class I
Status: Terminated
Initiated: 2013-03-26
Posted: 2013-05-03
Terminated: 2017-04-12
Recalling firm: Medtronic, Inc.
Product: A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit
Product code: OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Reason for recall: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Affected consignees were notified with a letter, dated March 26, 2013, sent via FedEx Priority, of this action. Cardinal Sales Representatives will also be advised and will verbally communicate the action to affected customers. The letter identified the affected product and the problem. Customers are to locate any affected product and quarantine them. In addition, clinicians should be informed of the issue; and, warning labels should be affixed to the front of each kit instructing users to remove and discard the Anesthesia Circuit and Filter Assembly. In order to confirm receipt of this action and completion of labeling the product, the enclosed Acknowledgement Form should be completed and returned to the number provided. If customers do now wish to accept overlabeled product or to overlabel the product in their possession, they are to contact Presource Sales Operations at 800-766-0706, or their sales representative for further instruction. Customers are to contact Cardinal Health Quality Systems at 800-292-9332, if they have any questions or need special assistance.
Quantity in commerce: 4,571 Kits total
Distribution: Distributed in the states of AR, MS, SC, and TN.
Product codes and lots: A) Catalog Number: PG24LCGWG02; Lots: 153502, 162892, 170494, 180482 88701, 193548, 198163, 206986; B) Catalog Number: PG24LCGWG; Lots:153502, 162892, 170494, 180482, 188701, 193548, 198163, 206986

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1194-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1193-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1194-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1195-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1196-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1197-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1198-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1199-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1200-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1201-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1202-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1203-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1204-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1205-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1206-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03

Product code OFP

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)