Custom Healthcare Systems recall
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Why was Custom Healthcare Systems recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
LOT NUMBER: 20190614, expires February 1, 2020 UNIQUE DEVICE IDENTIFIER: (01)00811870033261(17)200201(10)20190614
- Product
- Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
- Recalling firm
- Custom Healthcare Systems, Inc.
- Quantity
- 240 kits
- Distribution
- US Distribution to IL.
- Recall date
- February 5, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)