FDA Enforcement
Class II
Terminated
CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
Recall: Z-0268-2019
·
Reported October 31, 2018
Enforcement
- Recall Number
- Z-0268-2019
- Event ID
- 81179
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Custom Healthcare Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 31, 2018
- Initiation Date
- August 13, 2018
- Classification Date
- October 25, 2018
- Termination Date
- August 1, 2022
- Address
- 4205 Eubank Rd, N/A, Richmond, VA, 23231-4328, United States
Description
CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
Reason
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code Info
Lot Number: 61518 Exp. date: 8/1/2020
Distribution
Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
Quantity
300 units