FDA Device Recalls

Class IITerminated

ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

ARROW INTERNATIONAL Inc.

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 product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).

September 14, 2022 · DeviceView details →

Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.

Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table

Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position.

C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,

Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.

B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)

ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessory

cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.

Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91

CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545

Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360

VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.

Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.

Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007

DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.

Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.