Device 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.
Z-0932-2018
Product summary
- Event
- Event 79341
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,206 cases
- Official record key
device-enforcement:Z-0932-2018
Official wording
Reason: Product not meeting the iodine assay level requirements to support 36 month expiration dating.
Code information: Item 241, 100123, 100124, 82-15
Distribution pattern: US Distribution to states of: CO, FL, GA, KY, MI, MO, NC, NH, OH, TN, TX, WA, AND WI.
Derived failure modes
-
Unknown
Product not meeting the iodine assay level requirements to support 36 month expiration dating.