Device Recall DeRoyal Sterile Custom kits 의 리콜

Recall

78843

Class 2

Z-0334-2018

2017-12-19

Terminated

United States

2018-06-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160713

Deroyal manufactured custom sterile surgical kits containing the covidien-dover(tm) irrigation tray with piston syringe that contains the medline aplicare povidone iodine prep pads. the prep pads were subsequently recalled because medline aplicare determined the product would not support the 36 month expiration date listed on the label.

The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 12/19/2017 to its Consignees overnight. The letter describe the product, problem and actions to be taken. The Consignees were instructed to identify affected product; place in quarantine to prevent further use, and complete and return the Affected Products Listing form to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than 1/15/2018, even if you no longer have any inventory. If you have questions or need assistance with the recall, please email jmarsh@deroyal.com or call by phone 865-362-4203 or email us at recalls@deroyal.com.