Recall Z-1829-2017
Teleflex Medical · initiated March 29, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
Codes / lots: 4799431
Reason for recall
Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.
FDA-determined cause: Incorrect or no expiration date
Action taken
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.
Details
- Recall number
- Z-1829-2017
- Initiated
- March 29, 2017
- Posted by FDA
- April 4, 2017
- Terminated
- April 19, 2024
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- 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
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC