Recall Z-0575-2022— Baxter Healthcare Corporation

Name: FDA recall Z-0575-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-07

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-01-07. It names one FDA 510(k) clearance: K152675. Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482. 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-01-07
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTERBaxter Healthcare·cleared 2015-10-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.