FDA recall Z-0932-2018

Product

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.

Reason for recall

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

Distribution

US Distribution to states of: CO, FL, GA, KY, MI, MO, NC, NH, OH, TN, TX, WA, AND WI.

Key facts

Status

Terminated

Initiation date

2017-11-17

Report date

2018-03-14

Termination date

2020-04-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond, VA, United States

Primary source

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