Recall Z-0863-2020 ยท LRO General Surgery Tray
Custom Healthcare Systems, Inc.
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
| Date | Dec 20, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Labeling False and Misleading |
| Action | 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. |
| Quantity | 240 kits |
| Distribution | US Distribution to IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.