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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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