FDA recall Z-2548-2017

Medtronic · Class II · device

Product

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.

Distribution

Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

Key facts

Status
Terminated
Initiation date
2017-05-03
Report date
2017-06-21
Termination date
2019-07-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2548-2017