Recall Z-2337-2018— Terumo Medical Corp
Class II · Terminated
Class II FDA medical device recall by Terumo Medical Corp, initiated 2018-04-09, terminated 2019-04-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135. Reason: Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used..
- Recalling firm
- Terumo Medical Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-09
- Terminated
- 2019-04-19
- Firm location
- Somerset, NJ, United States
Product description
Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Reason for recall
Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.
Data sourced from openFDA. This site is unofficial and independent of the FDA.