Recalls / —

—#154446

Product

Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.

FDA product code

FMI — Needle, Hypodermic, Single Lumen

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K091140

Affected lot / code info

4799431

Why it was recalled

Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.

Root cause (FDA determination)

Incorrect or no expiration date

Action the firm took

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.

Recalling firm

Firm

Teleflex Medical

Address

2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern

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

Timeline

Recall initiated

2017-03-29

Posted by FDA

2017-04-04

Terminated

2024-04-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #154446. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.