Recall Z-1779-2018 ยท FMI Needle, Hypodermic, Single Lumen
MHC Medical Products LLC
EasyTouch (ET) Insulin Syringe 29G 1ml " (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
| Date | Apr 6, 2018 |
| Status | Open, Classified |
| Reason | The retail shelf cartons may be labeled with an incorrect lot number. |
| 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 im |
| Quantity | 3137 retail units (313700 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112789 | EASY TOUCH Mhc Medical Products, LLC, Dec 23, 2011 |