Recall Z-0268-2019— Custom Healthcare Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Custom Healthcare Systems, Inc., initiated 2018-08-13, terminated 2022-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- Custom Healthcare Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-13
- Terminated
- 2022-08-01
- Firm location
- Richmond, VA, United States
Product description
CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
Reason for recall
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Data sourced from openFDA. This site is unofficial and independent of the FDA.