Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-11-14FDA-DeviceZimmer Biomet, Inc.Class IIBiomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- 2018-11-14FDA-DeviceZimmer Biomet, Inc.Class IIBiomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- 2018-11-14FDA-DeviceZimmer Biomet, Inc.Class IIBiomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- 2018-11-14FDA-DeviceZimmer Biomet, Inc.Class IIBiomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- 2018-11-14FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia
The reagent pack exhibits the potential for an increased frequency of calibration failures.
- 2018-11-14FDA-DeviceOscor, Inc.Class ITB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use.
During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.
- 2018-11-14FDA-DeviceCordis CorporationClass IICordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
- 2018-11-14FDA-DeviceMedtest Holdings, Inc.Class IIIPointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
- 2018-11-14FDA-DeviceBecton Dickinson & CompanyClass IIPCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module directions for Use for complete loading and operating instructions. Notes: The set should be changed according to the facility protocol or in accordance w
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
- 2018-11-14FDA-DeviceBecton Dickinson & CompanyClass IIPCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module directions for Use for complete loading and operating instructions. Notes: The set should be changed according to the facility protocol or in accordance with
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
- 2018-11-14FDA-DeviceCareFusion 303, Inc.Class IIAlaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 2120-0500, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPE
Complaints where users were unable to prime the administration set.
- 2018-11-14FDA-DeviceBecton Dickinson & CompanyClass IIBD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) (see Figure below) incorporates a passive needle shielding mechanism that is activated as part of the usual insertion procedure when the needle is withdrawn from the catheter. BD Nexiva device is designed to protect the clinician from accidental needle stick injuries and min
One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.
- 2018-11-14FDA-DeviceQiagen Sciences LLCClass IIEZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of
An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be compromised and extractions need to be repeated. This could cause a delay in obtaining results from downstream applications.
- 2018-11-14FDA-DeviceRandox Laboratories Ltd.Class IILiquid Cardiac Control, CQ5053
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
- 2018-11-14FDA-DeviceRandox Laboratories Ltd.Class IILiquid Cardiac Control, CQ5052
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
- 2018-11-14FDA-DeviceRandox Laboratories Ltd.Class IILiquid Cardiac Control, CQ5051
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
- 2018-11-14FDA-DeviceAROA BIOSURGERYClass IIEndoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
Potential for pouch seal failure
- 2018-11-14FDA-DeviceAROA BIOSURGERYClass IIEndoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
Potential for pouch seal failure
- 2018-11-14FDA-DeviceAROA BIOSURGERYClass IIEndoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
Potential for pouch seal failure
- 2018-11-14FDA-DeviceColtene Whaledent IncClass IIParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
- 2018-11-14FDA-DeviceGE Healthcare, LLCClass IICentricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
Synchronization failure
- 2018-11-14FDA-DeviceGE Healthcare, LLCClass IICentricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
Synchronization failure
- 2018-11-14FDA-DeviceHowmedica Osteonics Corp.Class IISterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, or trauma surgeries.
Potential for outer pouch sterile barrier to be compromised
- 2018-11-14FDA-DeviceRoche Diagnostics CorporationClass ICoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;
Abnormally high INR test results with the affected CoaguChek test strips
- 2018-11-14FDA-DeviceOriGen Biomedical, Inc.Class IREF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
- 2018-11-07FDA-DeviceSiemens Medical Solutions USA, Inc.Class IIEVO Excel, Emission Computed Tomographic System, Material Number 10910501
The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,
- 2018-11-07FDA-Device3M Company - Health Care BusinessClass II3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
- 2018-11-07FDA-DeviceBaxter Healthcare CorporationClass IIEXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Potential ability to leak once used for compounding.
- 2018-11-07FDA-DeviceBaxter Healthcare CorporationClass IIEXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Potential ability to leak once used for compounding.
- 2018-11-07FDA-DeviceBaxter Healthcare CorporationClass IIEXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Potential ability to leak once used for compounding.
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