ARROW INTERNATIONAL Inc. recalls ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For…
Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for…
Read the official notice →- Date
- 2022-10-26
- Country
- United States
- Brand
- Arrow
- Product
- ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For…
- Classification
- Class II
- Units
- US Nationwide distribution in the state of Florida.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Arrow recalls
- 2023-09-27
USARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- 2023-06-28
- US
ARROW INTERNATIONAL Inc. recalls ARROW Endurance Extended Dwell Peripheral Catheter System
Potential for catheter separation or leakage
FDA · DeviceARROW INTERNATIONAL Inc.Nationwide distribution. International distribution to Canada.Official notice → - 2022-12-21
- US
ARROW INTERNATIONAL Inc. recalls Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- US
ARROW INTERNATIONAL Inc. recalls Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d)…
There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable…
FDA · DeviceARROW INTERNATIONAL Inc.US Distributor in states of: FL, GA, KY, OH, PA and WV.Official notice → - 2022-07-06
- US
ARROW INTERNATIONAL Inc. recalls Arrow Three-Lumen CVC
Gravity flow rates on the affected product lidstock are incorrect.
FDA · DeviceARROW INTERNATIONAL Inc.US Nationwide distribution in the states of Florida.Official notice → - 2021-11-24
- US
Arrow International Inc recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous…
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
FDA · DeviceArrow International IncWorldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE…Official notice →
Other drugs & medical recalls in the United States
- 2022-10-26
- US
MEDLINE INDUSTRIES, LP - Northfield recalls CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of CA and TX.Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide.Official notice → - US
BALT USA, LLC recalls Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Product pouch label does not match up with carton label
FDA · DeviceBALT USA, LLCWorldwide distribution - U.S. Nationwide distribution in the states of FL, GA,…Official notice → - US
Synthes (USA) Products LLC recalls SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide…
- US
Roche Molecular Systems, Inc. recalls cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing…
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
FDA · DeviceRoche Molecular Systems, Inc.International distribution in the countries of Austria, Belgium, Czech…Official notice → - US
Intersurgical Inc recalls Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on…