FDA Recall D-0608-2024

Fresenius Medical Care Holdings, Inc. · Waltham, MA

Class II Ongoing 695 days on record

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

Product

DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94

Lot / code: 24AU03024, exp. date 07/31/2025

Quantity: 183 cases

Reason for recall

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

Recall record

Recall number: D-0608-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2024-06-18
Classified by FDA Center: 2024-07-17
FDA published: 2024-07-24
Recalling firm: Fresenius Medical Care Holdings, Inc.
Firm location: Waltham, MA

Drug identification

Brand name(s): DELFLEX
Generic name(s): DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE
Manufacturer(s): Fresenius Medical Care Renal Therapies Group, LLC
NDC(s): 49230-206, 49230-209, 49230-212
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.

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