Medical DeviceJun 6, 2018
Arrow International 10 cc Luer-Slip Loss of Resistance Syringe recall — FDA Z-2016-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
June 2018 recalls — page 13
These records include useful source details for the selected month.
Medical DeviceJun 6, 2018
Torax Medical LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code recall — FDA Z-2041-2018
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Class IIFDA: TerminatedTorax Medical, Inc.
Medical DeviceJun 6, 2018
MEDLINE Sterile* Needle Counter, 40Ct recall — FDA Z-1933-2018
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle…
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceJun 6, 2018
Arrow International SnapLock" Catheter/Syringe Adapter recall — FDA Z-1962-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit recall — FDA Z-2000-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with recall — FDA Z-1996-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Joerns Healthcare P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER recall — FDA Z-2033-2018
Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses…
Class IIFDA: TerminatedJoerns Healthcare
Medical DeviceJun 6, 2018
Arrow International Continuous Nerve Block Needle recall — FDA Z-1958-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with recall — FDA Z-1979-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with recall — FDA Z-1995-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International ARROWg+ard Blue(R) Central Venous Catheterization Kit recall — FDA Z-1985-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International VPS TipTracker Stylet Accessory recall — FDA Z-2028-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Spring Wire Guide Introducer Needle recall — FDA Z-1960-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Echogenic Needle; Product codes: PN-00215-E and PN-00217-E recall — FDA Z-2022-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) recall — FDA Z-2001-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Genesee BioMedical Sternal Valve Retractors With Atrial and Aortic Rakes recall — FDA Z-1953-2018
Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the…
Class IIFDA: OngoingGenesee BioMedical, Inc.
Medical DeviceJun 6, 2018
Olsen Medical Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR recall — FDA Z-1943-2018
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Class IIFDA: TerminatedOlsen Medical
Medical DeviceJun 6, 2018
Arrow International Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) recall — FDA Z-1998-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Maximal Barrier Drape recall — FDA Z-1965-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Pressure Injectable Multi-Lumen Central Venous Catheterization Kit recall — FDA Z-1980-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG) recall — FDA Z-2014-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
NordicNeuroLab AS nordicICE 2.3.14 Image processing software package used by trained recall — FDA Z-2044-2018
An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior…
Class IIFDA: TerminatedNordicNeuroLab AS
Medical DeviceJun 6, 2018
Olsen Medical Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" recall — FDA Z-1945-2018
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Class IIFDA: TerminatedOlsen Medical
Medical DeviceJun 6, 2018
Philips Electronics HeartStart MRx Monitor/Defibrillator, Model No recall — FDA Z-2035-2018
The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.