Recall Z-0932-2018— Cypress Medical Products LLC
Class II · Terminated
Class II FDA medical device recall by Cypress Medical Products LLC, initiated 2017-11-17, terminated 2020-04-08. FDA's recall record names no specific 510(k) clearance for this event. 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: Product not meeting the iodine assay level requirements to support 36 month expiration dating..
- Recalling firm
- Cypress Medical Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-17
- Terminated
- 2020-04-08
- Firm location
- Richmond, VA, United States
Product 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 for recall
Product not meeting the iodine assay level requirements to support 36 month expiration dating.
Data sourced from openFDA. This site is unofficial and independent of the FDA.