FDA-Device2017-06-21Class II

SCHRITTMACHER ANGIO X3; Item Number: 4045255423347

Medtronic
Hazard

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

Sold states
Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
Affected count
478,465 (total for all products)
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
SCHRITTMACHER ANGIO X3; Item Number: 4045255423347

Official notice

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

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