Recall Z-1465-2014— Terumo Cardiovascular Systems Corp
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corp, initiated 2014-03-28, terminated 2014-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431. Reason: Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits.
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-28
- Terminated
- 2014-12-12
- Firm location
- Ashland, MA, United States
Product description
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Reason for recall
Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits
Data sourced from openFDA. This site is unofficial and independent of the FDA.