Draeger Medical, Inc. recalls Carina Sub-Acute Care Ventilator
Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
Read the official notice →- Date
- 2023-08-30
- Country
- United States
- Brand
- Draeger Medical
- Product
- Carina Sub-Acute Care Ventilator
- Classification
- Class I
- Units
- US Nationwide Distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Draeger Medical recalls
- 2024-12-25
USDraeger Medical, Inc. recalls Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in…
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger Medical, Inc.No Atlan A300 or A300XL devices were imported into the US. Devices were direct…Official notice →- 2024-11-20
- US
Draeger Medical, Inc. recalls Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger Medical, Inc.US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY,…Official notice → - 2024-04-24
- US
Draeger Medical, Inc. recalls Dr¿ger Perseus A500 Anesthesia Workstation
Unexpected shutdown while operating on battery power.
FDA · DeviceDraeger Medical, Inc.Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia,…Official notice → - 2023-07-19
- US
Draeger Medical, Inc. recalls Oxylog 3000 Plus emergency and transport ventilator
Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
FDA · DeviceDraeger Medical, Inc.Distributed Nationwide. OUS Distribution: Afghanistan, Algeria, Andorra,…Official notice → - 2023-05-24
- US
Draeger Medical, Inc. recalls VentStar Basic (P)180, MP00351
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 2023-03-01
- US
Draeger Medical, Inc. recalls NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
Other drugs & medical recalls in the United States
- 2023-08-30
- US
Boston Scientific Corporation recalls EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
- US
BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Due to manufacturing issue, panels may result in false negative results.
FDA · DeviceBioFire Diagnostics, LLCUS: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV…Official notice → - US
ICU Medical Inc recalls Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453,…
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- US
TMC Acquisitions LLC dba Tailor Made Compounding recalls Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
Lack of Assurance of Sterility
FDA · DrugTMC Acquisitions LLC dba Tailor Made CompoundingNationwide within the USAOfficial notice → - US
Inmar Supply Chain Solutions, LLC recalls All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage…
FDA · DrugInmar Supply Chain Solutions, LLCSeparate Distribution List (salvage buyers) provided by Inmar and will be…Official notice → - US
Baxter Healthcare Corporation recalls Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare…
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.