FDA Device

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.

Hazard

Kit was labeled with the incorrect Expiration Date of April 30, 2019.

What You Should Do

Remedy

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.

Products

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.
Brand
Terumo Cardiovascular Systems Corp
UPC
Lot Number: VE17

Units Affected

30 cases/2 units (Total 60 units)