B. Braun Medical, Inc. recalls TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous…
Read the official notice →- Date
- 2023-11-15
- Country
- United States
- Brand
- B. Braun Medical
- Product
- TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Canada and…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More B. Braun Medical recalls
- 2024-02-28
USB. Braun Medical, Inc. recalls Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the…
Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
- US
B. Braun Medical, Inc. recalls Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray…
Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
- 2023-12-13
- US
B. Braun Medical, Inc. recalls Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming…
In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy.…
- 2023-11-01
- US
B. Braun Medical, Inc. recalls 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to…
FDA · DeviceB. Braun Medical, Inc.Domestic distribution nationwide. Foreign distribution to Canada.Official notice → - 2023-10-04
- US
B. Braun Medical, Inc. recalls B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid…
The sterile blister packaging may be damaged, and sterility may be compromised
- 2023-09-27
- US
B. Braun Medical, Inc. recalls Perifix¿ / Epidural anesthesia set, medicated
Product may be mislabeled with an incorrect lid stock label.
FDA · DeviceB. Braun Medical, Inc.US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA,…Official notice →
Other drugs & medical recalls in the United States
- 2023-11-15
- US
Medtronic Navigation, Inc. recalls StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is…
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
FDA · DeviceMedtronic Navigation, Inc.Worldwide Distribution: U.S. (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice → - US
CareFusion 303, Inc. recalls Alaris PCA Module 8120
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
FDA · DeviceCareFusion 303, Inc.Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, DC, DE,…Official notice → - US
Baxter Healthcare Corporation recalls Novum IQ Syringe infusion system, Product Code 40800BAXUS
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS,…Official notice → - US
Pfizer Inc. recalls 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx…
Presence of Particulate Matter: identified as glass.
FDA · DrugPfizer Inc.Nationwide in the US and Puerto Rico. The products were not distributed to…Official notice → - US
Grato Holdings, Inc. recalls V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
FDA · DrugGrato Holdings, Inc.Distributed to one direct account in Florida with possible further…Official notice → - US
Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd,…
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.