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Terminated

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

FDA Recall Z-1829-2017 · Posted 2017-04-04

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeFMI
Date Initiated2017-03-29
Date Terminated2024-04-19
Product Quantity4760 eaches

Reason for Recall

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

Firm 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.

Root Cause

Incorrect or no expiration date

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091140EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IOVidacare Corporation · 2009-10-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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