FDA Medical Device Recalls (openFDA)
Centurion Medical Products Corporation: MINI PLASTICS SET
- Recall number
- Z-1081-2018
- Recalling firm
- Centurion Medical Products Corporation
- Product
- MINI PLASTICS SET
- Status
- Terminated
- Initiated
- 2017-10-23
- Posted
- not on file
- Terminated
- 2018-06-21
- Reason
- Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 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
- 75700 Lot codes: 2015102790 2016011590 2016030790 2016050490 2016062390 2016071590 2016081790 2016111890 2017012090 2017020790 2017042090
- 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