Z-0257-2019 Class II Terminated
FDA device recall Z-0257-2019 was initiated by Custom Healthcare Systems, Inc. on Aug 13, 2018 and is designated Class II. Reason for recall: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility The recall status is terminated (terminated Aug 1, 2022). Affected quantity: 150 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 31, 2018
- Initiation Date
- Aug 13, 2018
- Termination Date
- Aug 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 units
Product Description
CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591
Reason for Recall
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Distribution Pattern
Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
Code Information
Lot number: 52418 Exp. Date: 5/1/2021
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0257-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026