FDA-Device2018-03-14Class II

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.

Hazard

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

Sold states
US Distribution to states of: CO, FL, GA, KY, MI, MO, NC, NH, OH, TN, TX, WA, AND WI.
Affected count
12,206 cases
Manufactured in
9954 Mayland Dr Ste 4000, N/A, Richmond, VA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0932-2018

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