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.

Cypress Medical Products LLC
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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