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

FDA device recall Z-1829-2017 · posted 2017-04-04 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

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

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

FMI

Quantity affected

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

Date initiated

2017-03-29

Date posted

2017-04-04

Date terminated

2024-04-19

Location

Research Triangle Park, NC

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