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U.S. Department of Health and Human Services

Class 2 Device Recall Presource Kit Total Joint Pack

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  Class 2 Device Recall Presource Kit Total Joint Pack see related information
Date Initiated by Firm November 16, 2018
Create Date January 09, 2019
Recall Status1 Terminated 3 on November 04, 2019
Recall Number Z-0702-2019
Recall Event ID 81756
Product Classification General surgery tray - Product Code LRO
Product Presource Kit Total Joint Pack containing a double-wrapped basin component.

Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
Code Information Product code: SOP22TJCLK Lot numbers # 104405, 122793, and 987948
Recalling Firm/
Manufacturer		 Cardinal Health Inc.
7000 Cardinal Pl
Dublin OH 43017-1091
For Additional Information Contact Cardinal Customer Service
866-551-0533
Manufacturer Reason
for Recall		 The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action As only one customer is potentially impacted, in the interest of prompt action and notification, a teleconference was held on Friday, November 16, 2018 with the customer to communicate the impending actions. During this teleconference, the customer was informed that an HHE and field corrective action was in-process and that a study was being initiated to determine that their requested packaging configuration was acceptable. The customer also was informed that they should not continue to use the impacted double wrapped basin, and the components contained within, until the study was completed. Cardinal Health is following up on this teleconference with a written notification.
Quantity in Commerce 182 packs
Distribution US state of Florida
Total Product Life Cycle TPLC 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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