Recall archive
46 recalls · page 2 of 2
Reported Sep 11, 2019
ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — The filter capacity is not achieved due to damage of the filter membrane.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 10, 2018
CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connection device used by physicians to provide various…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has…
92 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 11, 2018
26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is…
FDA (openFDA device enforcement)
Reported Jul 4, 2018
Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.
FDA (openFDA device enforcement)
Reported Feb 21, 2018
Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand · Reason for recall — B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 7, 2016
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand · Reason for recall — Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.
FDA (openFDA device enforcement)
Reported Nov 9, 2016
Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand · Reason for recall — B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine…
FDA (openFDA device enforcement)
Reported Jun 8, 2016
Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2016
WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
FDA (openFDA device enforcement)
Reported Oct 28, 2015
Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
FDA (openFDA device enforcement)
Reported May 13, 2015
CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the…
FDA (openFDA device enforcement)
Reported Sep 24, 2014
B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand · Product · Product details — The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging…
FDA (openFDA device enforcement)
Reported Jul 16, 2014
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock…
FDA (openFDA device enforcement)
Reported Jun 4, 2014
Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand · Reason for recall — B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
FDA (openFDA device enforcement)
Reported Feb 26, 2014
SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The…
FDA (openFDA device enforcement)
Reported Feb 12, 2014
B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand · Product · Product details — Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time…
FDA (openFDA device enforcement)
Reported Jan 1, 2014
B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand · Product · Product details — One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.
FDA (openFDA device enforcement)
Reported Dec 4, 2013
20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2013
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined…
FDA (openFDA device enforcement)
Reported May 8, 2013
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane…
FDA (openFDA device enforcement)
Reported Jan 9, 2013
Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
Matched: Brand — Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.
FDA (openFDA device enforcement)
Reported Jul 25, 2012
Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.B. Braun Medical, Inc.
Matched: Brand — Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free…
FDA (openFDA device enforcement)
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