Medical Devices

Cardinal Health – Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit

Recall Class: Class I

Date Recall Initiated: March 26, 2013

Product: Various Presource Kits listed below

Manufacturing Dates: March 2012 – March 2013

Distribution Dates: March 2012 – February 2013

Product Codes and Lot Numbers

Product

Catalog Number

Lot Number(s)

Presource PBDS Gyn Laparoscopy Kits

PB24LSNPC01

152737
159630
168459
176674
187217
197319

Presource PBDS Lap Chole, Kit, Cleanup;

PG24LCGWG02

153502
162892
170494
180482
88701
193548
198163
206986

Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit

PG24LCGWG

153502
162892
170494
180482
188701
193548
198163
206986

Presource PBDS, General Laparoscopy, Kit, Circulator

PG24LGNPC01

14792
152554
160275
165822
173745
180700
186904
195042
205901
836989

Presource PBDS, Major Abdominal Kit, Circulator

PG24MANPC01

840143
857320
871000
882315
900599
928133
942238
952387
964048

Presource PBDS, Knee Arthroscopy, Kit, Circulator

PO24AKNPC01

851288
877594
901672
917786
948443
972424

Presource PBDS, Extremity, Kit, Circulator

PO24EXNPD01

852429
868825
883022
896400
914524
929984
941696
954317

Presource PBDS, Hand, Kit, Circulator

PO24HKGWG01

856515
875680
894983
905021
929987
932368
946822
954543
968547

Presource PBDS, Shoulder Arthroscopy, Kit, Circulator

PO24SAGWF01

847129
877843
905183
931801
935180
946651
957422
969585

Presource PBDS, Shoulder Procedure, Kit, Circulator

PO24SHNPC01

843685
864636
875004
893118
901720
924132
934399
959120
968668

Presource PBDS, Total Hip, Kit, Circulator

PO24THGWG01

966051
970753

Presource PBDS, Total Joint, Kit, Circulator

PO24TJNC01

843134
851291
875033
893475
911751
914529
928726
948543
968125

Presource PBDS, Total Knee, Kit, Circulator

PO24TKGWE01

828654
851596
872322
879459
885132
905305
920462
934298
946652
959208

Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit

PZ23ANBUG

200710

Presource PBDS, Knee Arthroscopy, Kit, Circulator

PO24KAGWE01

839276
851503
884374
905171
930617
946381
952446
959782

Use: Cardinal Health’s pre-assembled Filter and Anesthesia Circuit are intended to provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to a patient. These assemblies are included in various Presource convenience kits including, but not limited to, gynecology laparoscopy kits, general laparoscopy kits, knee arthroscopy kits, and total hip kits.

Recalling Firm:
Cardinal Health
1430 Waukegan Road MPKB
McGaw Park, Illinois 60085

Reason for Recall:
Cardinal Health discovered that various Presource Kits containing a pre-assembled anesthesia circuit and filter may contain outer plastic packaging on one or more components. If the packaging is removed without dissembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction in airflow. This may result in serious adverse health consequences including low blood oxygen (hypoxia), suffocation and death.

Public Contact: Questions should be directed to Cardinal Health Quality Systems at 1-800-292-9332.

FDA District: Chicago District Office

FDA Comments:
On March 26, 2013, Cardinal Health notified customers of the problem and products affected. Customers should examine their inventories, identify and locate the products affected, notify clinicians, and affix a WARNING LABEL on the front of each kit. The WARNING LABEL instructs clinicians to remove and discard the anesthesia circuit and filter assembly. Customers are also asked to confirm receipt of the notification letter and completion of the labeling activity by returning an Acknowledgement Form. If customers are not comfortable with adding the WARNING LABEL to the kits or using these kits, they should contact Cardinal Health at 1-800-766-0706 for further instructions.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Page Last Updated: 09/24/2013
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