Custom Healthcare Systems, Inc. Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

Custom Healthcare Systems, Inc. sent an "Urgent Medical Device Recall" letter dated January 7, 2020 and email message dated January 9, 2020 to its customer. the letter described the product, problem and actions to be taken. Customer was advised to CHECK YOUR INVENTORY AND QUARANTINE ANY AFFECTED PRODUCT. Contact John Chou at 804(421-5959) , or email j.chou@customhealthcaresystems.com, with regards to returning affected products. This recall should be carried out to the end user level. If you have distributed the product further, notify your accounts that received the product of this recall. Remaining product you have available for use should be scheduled for return and replacement or credit compensation. Medical Device Recall Return and Receipt Form provided to consignee for completion and return. If you have any further questions, contact Quality Assurance Manager, at 804-421-5959 or email: j.chou@customhealthcaresystem.com

Distribution

As reported by FDA

IL