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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-1829-2017
Recalling firm
Teleflex Medical
Product
Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
Status
Terminated
Initiated
2017-03-29
Posted
2017-04-04
Terminated
2024-04-19
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
Lot, serial or model codes
4799431
510(k) numbers
["K091140"]
PMA numbers
not on file
Product code
FMI
Firm FEI
3005747797
Firm city
Research Triangle Park
Firm state
NC
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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