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.
This recall has been terminated (originally issued November 17, 2017).
- Company
- Cypress Medical Products Llc
- Recall Initiated
- November 17, 2017
- Terminated
- April 8, 2020
- Recall Number
- Z-0932-2018
- Quantity
- 12,206 cases
- Firm Location
- Richmond, VA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Item 241, 100123, 100124, 82-15
Root Cause
Nonconforming Material/Component
Action Taken
The firm, Cypress Medical Products, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter dated 11/16/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately discontinue use of any product matching the affect items; If you have product affected by this notice, a recall label must be applied to each affected convenience kit. Please contact Cypress Medical Products, LLC customer service via email at cypress.customerservice@cypressmed.com to request the number of labels required. Upon opening the kit during procedure time, please dispose of the affected Aplicare Povidone Iodine Prep Pad in accordance with your institutions policies and procedures. If you have further distributed the product, please notify your customers and provide the customer with a copy of this notification. Complete and return the Reply form via email to: Cypress Medical Products LLC, Attn: Cypress Customer Service at: cypress.customerservice@cypressmed.com, even if you have no affected product. To ensure product availability, new orders for the affected convenience kits will be shipped with the affixed recall labels until new product is made available from the manufacturer. If you have any questions concerning this recall, please contact Cypress Customer Service at the email: cypress.customerservice@cypressmed.com.