Richmond, VA, United States
Custom Healthcare Systems, Inc. recalls
2 recalls recorded since 2018, most recently on 20 December 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 December 2019
- Terminated
- 1 August 2022
- 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.
- Distribution
- US Distribution to IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0863-2020
- Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Terminated Class II Medical devices
- Recall started
- 13 August 2018
- Terminated
- 1 August 2022
- Reason
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Distribution
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0244-2019, Z-0261-2019, Z-0243-2019, Z-0254-2019, Z-0260-2019, Z-0252-2019, Z-0247-2019, Z-0268-2019, Z-0267-2019, Z-0266-2019, Z-0259-2019, Z-0250-2019 and 17 more
- CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
- CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
- CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
- CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664
- CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
- CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
- CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
- CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
- and 21 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.