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U.S. Department of Health and Human Services

Class 1 Device Recall Presource PBDS

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 Class 1 Recall
Presource PBDS
see related information
Date Posted May 03, 2013
Recall Status1 Open
Recall Number Z-1194-2013
Recall Event ID 64736
Product Classification Anesthesia Breathing Circuit Kit (Adult & Pediatric) - Product Code OFP
Product A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit
Code Information 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
Recalling Firm/
Manufacturer
Cardinal Health, Medical Products & Services
1430 Waukegan Road
Attn V. Mueller Qa
Park City, Illinois 60085
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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