Retiro De Equipo (Recall) de EasyTouch (ET) Insulin Syringe

Recall

79950

Class 2

Z-1780-2018

2018-04-06

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164268

The retail shelf cartons may be labeled with an incorrect lot number.

Notification letters distributed on 4/6/18 and 4/11/18 included the following instructions: Please identify your total inventory for this device. The lot number for this device is a five-character, numeric representation (45014). This number can be located on the reverse side of the poly bag (immediate package) near the UDI /QR code. On the retail shelf carton, the lot number (45014) can be located on the rear panel near the UDI/QR code. Finally, the lot number (45014) can be located on the side panels of the case carton near the Item# and expiration date. Please take the following actions immediately: " Cease distribution of this lot number of devices; " Segregate the above described devices; " Complete the attached Consignee Reply Form and return it, even if you have no inventory on hand, to us using the enclosed self-addressed, stamped envelope, and " Return all unused devices from this lot in your inventory, if any, using via UPS Ground, UPS #A68W74 to the following address: MHC Medical Products, LLC c/o RXTPL 4200 Binion Way, Suite 200 Mason OH 45036 If you are a wholesaler (distributor), MHC is requesting that you notify any accounts or additional locations that may have received these recalled devices in lot 45014. If you prefer that MHC notify your customers, please provide MHC with a list of your companys customers that received or have been shipped the recalled lot 45014, including the customers name, shipping address, and contact phone number and/or e-mail address that you have on record. If you are a retail pharmacy, MHC is requesting you to notify your customers that received these recalled devices in lot 45014. Please instruct all customers to return the devices either to your pharmacy or instruct them to call the MHC customer service line (877-358-4342) and MHC will provide additional recall instructions directly to the customer. If you are a customer for whom MHC drop-ships devices to your end customer, please be aware that w