Presource Kit Total Joint Pack containing a recall: Sterility Concern
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement…
Why was Presource Kit Total Joint Pack containing a recalled?
The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product code: SOP22TJCLK Lot numbers # 104405, 122793, and 987948
- Product
- Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement…
- Recalling firm
- Cardinal Health Inc.
- Quantity
- 182 packs
- Distribution
- US state of Florida
- Recall date
- January 16, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)