Medical DeviceJun 6, 2018
Arrow International Percutaneous Sheath Introducer Kit with ARROWgard Blue Sheath and recall — FDA Z-2017-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
June 2018 recalls — page 15
These records include useful source details for the selected month.
Medical DeviceJun 6, 2018
Torax Medical LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code recall — FDA Z-2038-2018
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
Siemens Medical Solutions USA SOMATOM go.Now, Material Number 11061618 There is a potential recall — FDA Z-1939-2018
There is a potential for a software issue that may cause the need for necessary patient rescans.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceJun 6, 2018
Arrow International ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use recall — FDA Z-1982-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
ARROW JACC with Chlorag+ard Technology recall — FDA Z-2015-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International 5Fr. Catheter Clamp with Fastener; Product Code: CC-00005 recall — FDA Z-2007-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) recall — FDA Z-1974-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Medical Action Industries Inc recall — FDA Z-2043-2018
Product sterility potentially compromised.
Class IIFDA: TerminatedMedical Action Industries Inc.
Medical DeviceJun 6, 2018
Arrow International Maximal Barrier Drape recall — FDA Z-1964-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Roche Molecular Systems MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA recall — FDA Z-1956-2018
Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
Class IIFDA: TerminatedRoche Molecular Systems, Inc.
Medical DeviceJun 6, 2018
Arrow International 7Fr. Catheter Clamp with Fastener; Product Code: CC-00007 recall — FDA Z-2008-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International TheraCath(R) Epidural Catheter recall — FDA Z-2012-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block recall — FDA Z-1934-2018
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 VPS Rhythm ECG Accessory Pack recall — FDA Z-2027-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM recall — FDA Z-2023-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International PICC Catheter Trimmer recall — FDA Z-2020-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Siemens Medical Solutions USA SOMATOM Go.Up, Material Number 11061628 There is a potential recall — FDA Z-1940-2018
There is a potential for a software issue that may cause the need for necessary patient rescans.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceJun 6, 2018
Arrow International Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side recall — FDA Z-1976-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) recall — FDA Z-1999-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter recall — FDA Z-2005-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Olsen Medical Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle recall — FDA Z-1941-2018
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
MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold recall — FDA Z-1936-2018
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 Radial Artery Catheterization Kit recall — FDA Z-1970-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Maquet Datascope Corp - Cardiac Assist Division CARDIOSAVE Hybrid Intra-Aortic Balloon Pump recall — FDA Z-1928-2018
Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
Class IFDA: OngoingMaquet Datascope Corp - Cardiac Assist Division
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.