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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Brand and Cypress Brand convience Kits (Aplicare Povidone Iodine Prep Pad)

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  Class 2 Device Recall McKesson Brand and Cypress Brand convience Kits (Aplicare Povidone Iodine Prep Pad) see related information
Date Initiated by Firm November 17, 2017
Create Date March 08, 2018
Recall Status1 Terminated 3 on April 08, 2020
Recall Number Z-0932-2018
Recall Event ID 79341
Product Classification unknown device name - Product Code N/A
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.
Code Information Item 241, 100123, 100124, 82-15
Recalling Firm/
Manufacturer		 Cypress Medical Products LLC
9954 Mayland Dr Ste 4000
Richmond VA 23233-1464
For Additional Information Contact Jill Early
804-553-2146
Manufacturer Reason
for Recall		 Product not meeting the iodine assay level requirements to support 36 month expiration dating.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 12,206 cases
Distribution US Distribution to states of: CO, FL, GA, KY, MI, MO, NC, NH, OH, TN, TX, WA, AND WI.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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