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U.S. Department of Health and Human Services

Class 1 Device Recall Presource PBDS, Knee Arthroscopy, Kit, Circulator

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 Class 1 Device Recall Presource PBDS, Knee Arthroscopy, Kit, Circulatorsee related information
Date Initiated by FirmMarch 26, 2013
Date PostedMay 03, 2013
Recall Status1 Terminated 3 on April 12, 2017
Recall NumberZ-1206-2013
Recall Event ID 64736
Product Classification Anesthesia breathing circuit kit - Product Code OFP
ProductPresource PBDS, Knee Arthroscopy, Kit, Circulator
Code Information Catalog Number: PO24KAGWE01; Lots: 839276, 851503, 884374, 905171, 930617, 946381, 952446, 959782
Recalling Firm/
Manufacturer		 Cardinal Health, Medical Products & Services
1430 Waukegan Road
Attn V. Mueller Qa
Park City IL 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		Packaging process control
ActionAffected 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 Commerce4,571 Kits total
DistributionDistributed in the states of AR, MS, SC, and TN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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