Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Check against the official notice below — it lists the full affected range.
Custom Healthcare Systems, Inc. is recalling the Inpatient Dialysis Kit PAK-19244, a single-use dialysis kit. The recall affects 240 kits distributed to Illinois. The hazard involves a component called a 1961 TELFA PAD 2 X 3 that contains latex, but neither the case label nor the device label disclosed the presence of latex in the Medical Convenience Kit. The affected product has lot number 20190614 and an expiration date of February 1, 2020.
The presence of undisclosed latex in the kit poses a risk to patients with latex allergies. The recall record does not specify a remedy or recommended course of action for consumers who may have received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Distribution to IL. Quantity: 240 kits Lot/code info: LOT NUMBER: 20190614, expires February 1, 2020 UNIQUE DEVICE IDENTIFIER: (01)00811870033261(17)200201(10)20190614
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.