Recall Z-2548-2017— Medtronic

Name: FDA recall Z-2548-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-03

Class II · Terminated

Class II FDA medical device recall by Medtronic, initiated 2017-05-03, terminated 2019-07-18. FDA's recall record names no specific 510(k) clearance for this event. Product: SCHRITTMACHER ANGIO X3; Item Number: 4045255423347. Reason: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material..

Recalling firm: Medtronic
Classification: Class II
Status: Terminated
Initiated: 2017-05-03
Terminated: 2019-07-18
Firm location: North Haven, CT, United States

Product description

SCHRITTMACHER ANGIO X3; Item Number: 4045255423347

Reason for recall

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

Data sourced from openFDA. This site is unofficial and independent of the FDA.