Home / Recalls / B. Braun Medical Inc. / D-1083-2023

D-1083-2023 Class III Terminated

Recalled by B. Braun Medical Inc. — Daytona Beach, FL

Recall Details

Product Type
Drugs
Report Date
August 16, 2023
Initiation Date
August 2, 2023
Termination Date
July 7, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43,812 bags

Product Description

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

Reason for Recall

Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

Distribution Pattern

United States

Code Information

Lot #: 0061852531, Exp 2/28/2025

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  • 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)