Z-0264-2019 Class II Terminated
FDA device recall Z-0264-2019 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: 7200 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
- 7200 units
Product Description
CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L
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 numbers: W72018, W71218 Exp Date:7/1/2021
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0264-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026