Medical device recalls Moderate risk

Cypress Medical Products LLC recalls 241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit…

Recall date
November 17, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0932-2018
FDA classification
Class II
Brand / firm
Cypress Medical Products LLC
Sold / distributed
US Distribution to states of: CO, FL, GA, KY, MI, MO, NC, NH, OH, TN, TX, WA, AND WI.

Why it was recalled

Product not meeting the iodine assay level requirements to support 36 month expiration dating.

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

What was recalled

241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress Medical Products Skin Staple Remover Kit. McKesson Item # 241, 100123, and 100124, Cypress Item # 82-15 Manual surgical instrument for general use.

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