Device Recall McKesson Brand and Cypress Brand convience Kits (Aplicare Povidone Iodine Prep Pad) 의 리콜

Recall

79341

Class 2

Z-0932-2018

2017-11-17

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162073

Product not meeting the iodine assay level requirements to support 36 month expiration dating.

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.