Other Medical Devices Recalls

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0

Angiodynamics Inc. (Navilyst Medical Inc.)

Class I - Dangerous

Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

Apr 17, 2019 Other Medical Devices Nationwide View Details →

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F

OriGen Biomedical

Class I - Dangerous

Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.

Jan 17, 2017 Other Medical Devices Nationwide View Details →

2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.

Fresenius Medical Care Renal Therapies Group

Class I - Dangerous

Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

Apr 3, 2019 Other Medical Devices Nationwide View Details →

Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

Stryker

Class I - Dangerous

The heated tube sets were consistently leaking and detaching from the cassette.

Mar 7, 2019 Other Medical Devices Nationwide View Details →

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F

OriGen Biomedical

Class I - Dangerous

Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.

Jan 17, 2017 Other Medical Devices Nationwide View Details →

Sterile Nail Clipper Concave Edge (67710)

Centurion Medical Products

Class I - Dangerous

Compromised seal on the sterile barrier pouch.

Mar 29, 2019 Other Medical Devices Nationwide View Details →

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

Angiodynamics Inc. (Navilyst Medical Inc.)

Class I - Dangerous

Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

Apr 17, 2019 Other Medical Devices Nationwide View Details →

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

Smiths Medical ASD

Class I - Dangerous

Packaged with an incorrect size inner cannula.

Feb 11, 2019 Other Medical Devices Nationwide View Details →

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

Angiodynamics Inc. (Navilyst Medical Inc.)

Class I - Dangerous

Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

Apr 17, 2019 Other Medical Devices Nationwide View Details →

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

Kerr/Pentron

Class I - Dangerous

Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.

Jul 13, 2018 Other Medical Devices Nationwide View Details →

NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical

Class I - Dangerous

Certain lots were mislabeled with incorrect product number.

Apr 11, 2019 Other Medical Devices Nationwide View Details →

Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

Microbiologics

Class I - Dangerous

Product with incorrect shelf life.

Apr 9, 2019 Other Medical Devices Nationwide View Details →

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0

Angiodynamics Inc. (Navilyst Medical Inc.)

Class I - Dangerous

Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

Apr 17, 2019 Other Medical Devices Nationwide View Details →

TLS2 Thermal Ligating Shears, Catalog Number 132-131D

Microline Surgical

Class I - Dangerous

The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.

Mar 22, 2019 Other Medical Devices View Details →

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F

OriGen Biomedical

Class I - Dangerous

Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.

Jan 17, 2017 Other Medical Devices Nationwide View Details →

Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Zimmer Biomet

Class I - Dangerous

Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.

Nov 14, 2018 Other Medical Devices View Details →

Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

Microbiologics

Class I - Dangerous

Product with incorrect shelf life.

Apr 9, 2019 Other Medical Devices Nationwide View Details →

Sterile Nail Nipper, Barrel Spring (I68400), Sterile

Centurion Medical Products

Class I - Dangerous

Compromised seal on the sterile barrier pouch.

Mar 29, 2019 Other Medical Devices Nationwide View Details →

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F

OriGen Biomedical

Class I - Dangerous

Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.

Jan 17, 2017 Other Medical Devices Nationwide View Details →

NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical

Class I - Dangerous

Certain lots were mislabeled with incorrect product number.

Apr 11, 2019 Other Medical Devices Nationwide View Details →