Z-1086-2018 Class II Terminated
FDA device recall Z-1086-2018 was initiated by Centurion Medical Products Corporation on October 23, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 21, 2018). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- October 23, 2017
- Termination Date
- June 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
TUBING CHANGE KIT
Reason for Recall
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.
Distribution Pattern
Nationally
Code Information
DT6870 Lot codes: 2015110290 2016090890 2017042690