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FDA Medical Device Recalls (openFDA)

Teleflex Medical: Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only

Recall number
Z-2251-2017
Recalling firm
Teleflex Medical
Product
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Status
Terminated
Initiated
2017-05-09
Posted
not on file
Terminated
2025-01-16
Reason
Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
Root cause
Unknown/Undetermined by firm
Action
Consignees were notified via letter on May 9, 2017.
Quantity
1150 units
Distribution
CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
Lot, serial or model codes
Product Code: 1101, Lot numbers: 74J1603122, 74K1601506, 74K1602306 and 74L16006.
510(k) numbers
not on file
PMA numbers
not on file
Product code
CAT
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

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