FDA Medical Device Recalls (openFDA)
Centurion Medical Products Corporation: GENERAL PURPOSE INSTRUMENT TRAY
- Recall number
- Z-1080-2018
- Recalling firm
- Centurion Medical Products Corporation
- Product
- GENERAL PURPOSE INSTRUMENT TRAY
- 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
- 75121 75175 71435 75455 75690 SR245 Lot codes: 2017071990 2016110990 2016040790 2017022090 2016112490 2017010390 2017082390 2015101290 2015111790 2016032290 2016051790 2016053090 2016102490 2017013190 2017032990 2017080290 2015110390 2016010490 2016012090 2016020890 2016041890 2016061390 2016090590 2016110790 2017010990 2017021390 2017032190 2015092190 2015120190 2015121490 2016022590 2016120190 2017010390 2017011090 2015093090 2015112390 2016020390 2016092290 2016091590
- 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