Recall Z-0571-2022 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
| Date | Jan 7, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Other |
| Action | 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 |
| Quantity | 2,553,528 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152675 | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADA Baxter Healthcare, Oct 29, 2015 |