FDA Recall D-0587-2024

Baxter Healthcare Corporation · Deerfield, IL

Class II Ongoing 696 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01

Lot / code: Lot R24B25FA; Exp. 2/28/2026

Quantity: 6,874 bags

Reason for recall

Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.

Recall record

Recall number: D-0587-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide, Canada
Recall initiated: 2024-06-17
Classified by FDA Center: 2024-07-06
FDA published: 2024-07-17
Recalling firm: Baxter Healthcare Corporation
Firm location: Deerfield, IL

Drug identification

Brand name(s): DIANEAL LOW CALCIUM WITH DEXTROSE
Generic name(s): SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE
Manufacturer(s): Vantive US Healthcare LLC
NDC(s): 0941-0409, 0941-0411, 0941-0413, 0941-0415, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433, 0941-0484, 0941-0487, 0941-0490
Route(s): INTRAPERITONEAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls