FDA Medical Device Recalls (openFDA)
Centurion Medical Products Corporation: PEDIATRIC IV & IV START KIT
- Recall number
- Z-1092-2018
- Recalling firm
- Centurion Medical Products Corporation
- Product
- PEDIATRIC IV & IV START KIT
- Status
- Terminated
- Initiated
- 2017-10-23
- Posted
- not on file
- Terminated
- 2018-06-21
- Reason
- Convenience Kit containing components to assist practitioner with IV placement and securement.
- Root cause
- Nonconforming Material/Component
- Action
- On October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall.
- Quantity
- not on file
- Distribution
- Nationally
- Lot, serial or model codes
- IV5785 IV6135 Lot codes: 2015121890 2016031490 2016102490 2016111490 2017012390 2017050890 2016071190 2015101990 2015120790 2016010490 2016012590 2016101090 2017010290 2017061990 2017071090
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRP
- Firm FEI
- 3008403546
- Firm city
- Williamston
- Firm state
- MI
- 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