Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
This recall has been terminated (originally issued May 12, 2017).
- Recall Initiated
- May 12, 2017
- Terminated
- October 26, 2018
- Recall Number
- Z-2550-2018
- Quantity
- 30 cases/2 units (Total 60 units)
- Firm Location
- Ashland, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
Distribution
US state of FL
Lot / Code Info
Lot Number: VE17
Root Cause
Incorrect or no expiration date
Action Taken
On May 12, 2017 Terumo Cardiovascular Systems Corporation telephoned their one client and notified them of the labeling error and asked them to hold product. All product was immediately quarantined.
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