Recall Z-3041-2017
Baxter Healthcare Corporation · initiated July 5, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
Codes / lots: all codes
Reason for recall
Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis (PD) therapy, damaging the cassettes for the HomeChoice or HomeChoice PRO cyclers. If damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region and the cycler may deliver air into the patient.
FDA-determined cause: Use error
Action taken
The firm notified their consignees by letter on 07/05/2017 of the potential for damaging the disposable set if tools are used to open the packaging and directing them to only open the packaging by hand by letter.
Details
- Recall number
- Z-3041-2017
- Initiated
- July 5, 2017
- Terminated
- October 5, 2020
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 23732 units
- Distribution
- Worldwide Distribution
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3040-2017 Class II | HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The…Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the… | 07/05/2017Terminated |