—#191277

Product

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482

FDA product code: KDJ — Set, Administration, For Peritoneal Dialysis, Disposable
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K152675
Affected lot / code info: All lot numbers within expiry

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2022-01-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191277. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.