Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- January 7, 2022
- Recall Number
- Z-0576-2022
- Quantity
- 62,712 units
- Firm Location
- Deerfield, IL
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.
Distribution
Worldwide
Lot / Code Info
All lot numbers within expiry
Root 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.