Medical device recalls Moderate risk

Medtronic recalls USPACK-SUTURE KIT; Item Number: US1672

Recall date
May 3, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2546-2017
FDA classification
Class II
Brand / firm
Medtronic
Sold / distributed
Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

USPACK-SUTURE KIT; Item Number: US1672

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