FDA Enforcement
Class II
Terminated
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.
Recall: Z-0932-2018
·
Reported March 14, 2018
Enforcement
- Recall Number
- Z-0932-2018
- Event ID
- 79341
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cypress Medical Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 14, 2018
- Initiation Date
- November 17, 2017
- Classification Date
- March 8, 2018
- Termination Date
- April 8, 2020
- Address
- 9954 Mayland Dr Ste 4000, N/A, Richmond, VA, 23233-1464, United States
Description
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
Product not meeting the iodine assay level requirements to support 36 month expiration dating.
Code Info
Item 241, 100123, 100124, 82-15
Distribution
US Distribution to states of: CO, FL, GA, KY, MI, MO, NC, NH, OH, TN, TX, WA, AND WI.
Quantity
12,206 cases