Z-1780-2018Class II

EasyTouch (ET) Insulin Syringe 29G 0.5ml " (Item 829555)

Name: Z-1780-2018 EasyTouch (ET) Insulin Syringe 29G 0.5ml " (Item 829555)
Creator: MHC Medical Products LLC
Published: 2018-04-06
License: https://open.fda.gov/license/

MHC Medical Products / initiated 2018-04-06 / Open, Classified / root cause: labeling and UDI

FDA source

MHC Medical Products LLC began a recall of EasyTouch (ET) Insulin Syringe 29G 0.5ml " (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY on 2018-04-06. FDA classified it as Class II and gives the reason as "The retail shelf cartons may be labeled with an incorrect lot number". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1780-2018
Classification: Class II
Status: Open, Classified
Initiated: 2018-04-06
Posted: 2018-05-09
Recalling firm: MHC Medical Products
Product: EasyTouch (ET) Insulin Syringe 29G 0.5ml " (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: The retail shelf cartons may be labeled with an incorrect lot number.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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
Quantity in commerce: 46600 syringes
Distribution: US Nationwide Distribution in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, ND, NH, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, WV, and Puerto Rico.
Product codes and lots: Lot 45016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1780-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1779-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1780-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-05-16	2018-05-09

Product code FMI

K112789Class IIEasy TouchMhc Medical Products, LLC / cleared 2011-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)