Home / Recalls / B. Braun Medical, Inc. / D-0076-2023

D-0076-2023 Class II Terminated

Recalled by B. Braun Medical, Inc. — Allentown, PA

Recall Details

Product Type
Drugs
Report Date
December 14, 2022
Initiation Date
November 25, 2022
Termination Date
August 23, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
756 bags

Product Description

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

Reason for Recall

Lack of sterility assurance: Bags have the potential to leak.

Distribution Pattern

FL, NJ, PA

Code Information

Lot: 0061832446 Exp. 31 Oct 2024

Other recalls by B. Braun Medical, Inc.

  • D-0353-2025 Class II — 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Pl (March 31, 2025)
  • Z-1021-2025 Class II — Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of an (December 4, 2024)
  • Z-3144-2024 Class II — AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, (August 8, 2024)
  • D-0638-2024 Class I — 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun M (July 24, 2024)
  • Z-2387-2024 Class II — Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered (June 17, 2024)
  • Z-2398-2024 Class II — Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-po (June 17, 2024)
  • Z-2404-2024 Class II — OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infus (June 17, 2024)
  • Z-2379-2024 Class II — Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powe (June 17, 2024)
  • Z-2389-2024 Class II — Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powe (June 17, 2024)
  • Z-2385-2024 Class II — Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-power (June 17, 2024)