Recall Z-0576-2022
Baxter Healthcare Corporation · initiated January 7, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
Codes / lots: All lot numbers within expiry
Reason for recall
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
FDA-determined cause: Other
Action taken
Baxter disseminated a Urgent Medical Device Correction letter on 7 January 2022 to peritoneal dialysis centers and will follow with notice to the patients on 12 January 2022. The notices warned that the use of cleaning products and solvents may cause damage (for example, leaking or cracking), if they come into direct contact with the transfer set. Baxter will be updating the Instructions for Use (IFU) to include a warning against the use of these cleaning products and solvents. For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176.
Details
- Recall number
- Z-0576-2022
- Initiated
- January 7, 2022
- Product code
- KDJ – Set, Administration, For Peritoneal Dialysis, Disposable
- Quantity
- 62,712 units
- Distribution
- Worldwide
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0570-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | 01/07/2022Open, Classified |
| Z-0571-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | 01/07/2022Open, Classified |
| Z-0572-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | 01/07/2022Open, Classified |
| Z-0573-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJCleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | 01/07/2022Open, Classified |
| Z-0574-2022 Class II | Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de…Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | 01/07/2022Open, Classified |
| Z-0575-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | 01/07/2022Open, Classified |
| Z-0577-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | 01/07/2022Open, Classified |
| Z-0578-2022 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | 01/07/2022Open, Classified |
| Z-0579-2022 Class II | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | 01/07/2022Open, Classified |
| Z-0580-2022 Class II | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents… | 01/07/2022Open, Classified |