Recall Z-0863-2020— Custom Healthcare Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Custom Healthcare Systems, Inc., initiated 2019-12-20, terminated 2022-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit. Reason: A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX..
- Recalling firm
- Custom Healthcare Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-20
- Terminated
- 2022-08-01
- Firm location
- Richmond, VA, United States
Product description
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Reason for recall
A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX.
Data sourced from openFDA. This site is unofficial and independent of the FDA.