B Braun Medical Inc recalls PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog…
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy,…
Read the official notice →- Date
- 2022-03-30
- Country
- United States
- Brand
- B. Braun Medical
- Product
- PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog…
- Classification
- Class II
- Units
- US Distribution to states of: MA, VT
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-10-26
USB. Braun Medical, Inc. recalls ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and…
The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream…
FDA · DeviceB. Braun Medical, Inc.Distribution US nationwide, Canada and Saudi Arabia.Official notice →- 2022-10-12
- US
B Braun Medical Inc recalls Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Potential for leakage at the catheter hub.
FDA · DeviceB Braun Medical IncDomestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign…Official notice → - 2022-04-20
- US
B Braun Medical Inc recalls Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number…
Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration…
- 2022-03-23
- US
B. Braun Medical, Inc. recalls 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Lack of sterility assurance: leaking bags
- 2022-03-16
- US
B. Braun Medical, Inc. recalls Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of…
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays…
FDA · DeviceB. Braun Medical, Inc.US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC,…Official notice → - 2021-10-06
- US
B. Braun Medical, Inc. recalls PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of…
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
FDA · DeviceB. Braun Medical, Inc.Worldwide distribution - US Nationwide distribution and the country of Canada.Official notice →
Other drugs & medical recalls in the United States
- 2022-03-30
- US
Ace Surgical Supply Co., Inc. recalls NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
FDA · DeviceAce Surgical Supply Co., Inc.Worldwide distribution - US Nationwide distribution in the states of GA, NY,…Official notice → - US
Dollar Tree Distribution, Inc. recalls Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri…
Potential exposure to rodents and rodent activity in the distribution center.
FDA · DeviceDollar Tree Distribution, Inc.US Nationwide distribution: Alabama, Arkansas, Louisiana, Mississippi,…Official notice → - US
Baxter Healthcare Corporation recalls Compella Therapy Air Supply Unit
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Integra LifeSciences Corp. recalls Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device…
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the country of Hong Kong.Official notice → - US
Cytocell Ltd. recalls TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome…
May show unexpected locus specific signals in addition to those at 14q32.
- US
Outset Medical, Inc. recalls Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
FDA · DeviceOutset Medical, Inc.U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE,…Official notice →