Recall Z-1829-2017 ยท FMI Needle, Hypodermic, Single Lumen
Teleflex Medical
Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
| Date | Apr 4, 2017 (initiated Mar 29, 2017) |
| Status | Terminated |
| Reason | Some of the individual unit packaging (pouches) may be missing the lot number an expiration date. |
| Root cause | Incorrect or no expiration date |
| Action | Consignees were notified of the recall by letter on March 29, 2017. The letter requested that they check their inventory and immediately discontinue use and quarantine any product and to inspect on hand for missing lot numbers and expiration date. The letter included a reply form to be returned to Teleflex. A separate letter was sent to distributors requesting a sub-recall. |
| Quantity | 4760 eaches |
| Distribution | AL, AK, AZ AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, Canada and Costa Rica |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091140 | EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO Vidacare Corporation, Oct 14, 2009 |