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

FDA device recall Z-1194-2013 · posted 2013-05-03 · Terminated

Recall details

Recalling firm

Cardinal Health, Medical Products & Services

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.

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

OFP

Quantity affected

4,571 Kits total

Distribution

Distributed in the states of AR, MS, SC, and TN.

Date initiated

2013-03-26

Date posted

2013-05-03

Date terminated

2017-04-12

Location

Park City, IL