Alerts Tracker – Medical Devices

Alerts Tracker – Medical Devices - Supplies 4/25/2024 7:22:19 AM 4/25/2024 7:22:19 AM Technicality—Needle Guide Trumpets: Trumpet Ring May Detach When Excessive Pressure is Applied https://alerts.ecri.org/alerts/view/details/1656757 4/24/2024 8:25:41 PM DOD/FDA SHELF-LIFE EXTENSION PROGRAM (SLEP) - PYRIDOSTIGMINE BROMIDE TABLETS USP 30MG I.S. 210 TABS/PACKAGE NO LONGER SLEP-ELIGIBLE (DOD MMQC-24-1022) https://alerts.ecri.org/alerts/view/details/1656794 4/24/2024 4:11:17 PM Dutch Ophthalmic—Directional Laser Probes: May Exhibit Difficulties Extending or Retracting Laser Fiber https://alerts.ecri.org/alerts/view/details/1656716 4/24/2024 1:33:42 PM Hologic—Aptima CMV Quant Assays: May Yield Error Code and Sample Invalidation https://alerts.ecri.org/alerts/view/details/1656718 4/24/2024 1:15:45 PM Thommen—Impression Copings: May Not Firmly Connect to Implant https://alerts.ecri.org/alerts/view/details/1656717 4/24/2024 1:09:59 PM DeRoyal—GeoMed Custom Surgical TraceCarts: May Contain Recalled Nurse Assist 16 Fr Silver Urine Meter Foley [FDA Class I] https://alerts.ecri.org/alerts/view/details/1656719 4/24/2024 12:58:19 PM Concordance—Cardinal Health X-Large Curity Flexible Adhesive Bandages: May Be Contaminated with Latex Adhesive Residual https://alerts.ecri.org/alerts/view/details/1656787 4/24/2024 12:30:52 PM Medline—Medline-Labeled Syringes: May Exhibit Leaks, Breakage, and other Quality Problems https://alerts.ecri.org/alerts/view/details/1656781 4/24/2024 12:22:00 PM NxStage—PureFlow Bicarbonate Dialysis Solution Bags: May Rupture during Mixing [ECRI Exclusive Hazard Report] https://alerts.ecri.org/alerts/view/details/1656790 4/24/2024 12:13:34 PM Medical Action Industries—Intravenous Start Kits: May Contain Saline Flush Syringes Recalled by Supplier https://alerts.ecri.org/alerts/view/details/1656745 4/24/2024 10:12:24 AM Exactech—Optetrak Patella Implants: Defective Packaging May Cause Accelerated Device Wear https://alerts.ecri.org/alerts/view/details/1656768 4/24/2024 10:03:26 AM Randox—Microalbumin Calibrator Series: May Exhibit Negative Bias https://alerts.ecri.org/alerts/view/details/1656779 4/24/2024 9:10:57 AM Actim—Prom Tests: May Yield Erroneous Results https://alerts.ecri.org/alerts/view/details/1656765 4/24/2024 9:01:58 AM Cardinal Health—Roche Accu-Chek Safe-T-Pro Lancets: Manufacturer Updates Intended Use to Include Patient Self-Testers https://alerts.ecri.org/alerts/view/details/1656739 4/24/2024 7:43:59 AM McKesson Medical-Surgical—InfuTronix Nimbus Infusion Pumps: May Exhibit Multiple Potential Failure Modes; Manufacturer Removes from Market https://alerts.ecri.org/alerts/view/details/1656713 4/23/2024 5:04:33 PM Medline—Siemens DCA Systems Hemoglobin A1c Reagent Kits: May Exhibit Positive Bias https://alerts.ecri.org/alerts/view/details/1656715 4/23/2024 4:59:46 PM Medtronic—SonarMed Air Wave Monitors: Software Anomaly May Fail to Detect Partial Obstruction [FDA Class I] https://alerts.ecri.org/alerts/view/details/1656773 4/23/2024 2:59:25 PM Medtronic—SonarMed Sensors Used with AirWave Monitors: May Fail to Detect Partial Obstruction [FDA Class I] https://alerts.ecri.org/alerts/view/details/1656764 4/23/2024 2:57:40 PM McKesson Medical-Surgical—Roche Accu-Chek Safe-T-Pro Lancets: Manufacturer Updates Intended Use to Include Patient Self-Testers https://alerts.ecri.org/alerts/view/details/1656730 4/23/2024 2:54:22 PM Integra—Cranial Access Kits: Sterility May Be Compromised https://alerts.ecri.org/alerts/view/details/1656770 4/23/2024 2:24:29 PM BD—Alaris Pump Infusion Sets: Drip Chamber May Detach from Tubing https://alerts.ecri.org/alerts/view/details/1656754 4/23/2024 1:38:34 PM Roche—Accu-Chek Safe-T-Pro Lancets: Manufacturer Updates Intended Use to Include Patient Self-Testers https://alerts.ecri.org/alerts/view/details/1656731 4/23/2024 1:26:16 PM Cook—NGage Salivary Stone Extractors: May Be Labeled with Incorrect Device Name https://alerts.ecri.org/alerts/view/details/1656751 4/23/2024 12:59:43 PM Elekta—Disposable Biopsy Needle Kits for Leksell Stereotactic Systems: May Contain Microscopic Debris Inside Biopsy Needle [FDA Class 1] https://alerts.ecri.org/alerts/view/details/1656756 4/23/2024 11:50:58 AM Karl Storz—Various Products: Reprocessing Method May Not Have Been Adequately Validated [MHRA FSN 29245989] https://alerts.ecri.org/alerts/view/details/1656784 4/23/2024 11:23:00 AM McKesson Medical-Surgical—Cardinal Health X-Large Curity Flexible Adhesive Bandages: May Be Contaminated with Latex Adhesive Residual https://alerts.ecri.org/alerts/view/details/1656769 4/23/2024 9:48:51 AM Cardinal Health—X-Large Curity Flexible Adhesive Bandages: May Be Contaminated with Latex Adhesive Residual https://alerts.ecri.org/alerts/view/details/1656767 4/23/2024 9:47:14 AM Isologic Innovative Radiopharmaceuticals—I-131 Diagnostic Capsules: May Exhibit Decreased Thyroid Uptake https://alerts.ecri.org/alerts/view/details/1656750 4/23/2024 8:40:14 AM Bound Tree—Emergency Products & Research Optimum Traction Devices: Adhesive May Fail to Secure Pole Insert https://alerts.ecri.org/alerts/view/details/1656746 4/23/2024 8:22:57 AM BD—Foley Catheter and Intermittent Catheter Trays: Trays May Not Contain Sterile Gloves during Supply Disruption https://alerts.ecri.org/alerts/view/details/1656740 4/22/2024 3:01:12 PM Stryker—Trident II Hemispherical and PSL Shells: Acetabular Shell May Exhibit Excessive Deburring [MHRA FSN 28144258] https://alerts.ecri.org/alerts/view/details/1656761 4/19/2024 3:56:31 PM Microbiologics—KWIK-STIK Rhizopus stolonifer Quality Control Kits: May Be Contaminated with Aspergillus brasiliensis https://alerts.ecri.org/alerts/view/details/1656721 4/19/2024 10:30:33 AM Vyaire—Twin Tube and Twin Tube Probenschlauch Sample Tubes: Nozzle May Separate During Use https://alerts.ecri.org/alerts/view/details/1656714 4/19/2024 9:40:53 AM X-Nav—X-Guide Handpiece Adapters: May Not Fit in Handpiece https://alerts.ecri.org/alerts/view/details/1656733 4/18/2024 9:16:19 PM Zimmer Biomet—Size E And Size E Minus Nexgen CR-Flex Femoral Components: Tensile May Be Out of Specification https://alerts.ecri.org/alerts/view/details/1656743 4/18/2024 2:55:07 PM GE HealthCare—CRITIKON ONE-CUF Blood Pressure Cuffs: May Exhibit Inaccurate Noninvasive Blood Pressure Measurements https://alerts.ecri.org/alerts/view/details/1656723 4/18/2024 2:09:33 PM Unomedical—Neria Soft Infusion Sets: Specific Lots Have Been Shipped into U.S. Market with Incorrect Instruction for Use within the Final Pack https://alerts.ecri.org/alerts/view/details/1656727 4/18/2024 1:14:41 PM Ossur—Rheo Knee and Rheo Knee XC Prostheses: May Exhibit Unintended Device Warnings, Potentially Triggering Device Shutdown https://alerts.ecri.org/alerts/view/details/1656737 4/18/2024 1:12:27 PM Surgical Specialties—POLYSIN Sutures: Needle Curvature May Be Incorrect https://alerts.ecri.org/alerts/view/details/1656705 4/18/2024 12:24:50 PM Abbott—Aveir VR Leadless Pacemakers: Electromagnetic Interference May Cause Mode Change https://alerts.ecri.org/alerts/view/details/1656729 4/16/2024 10:29:32 PM Aruba Aloe Balm—Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel: May Contain Methanol https://alerts.ecri.org/alerts/view/details/1656702 4/16/2024 10:09:34 PM bioMerieux—VITEK 2 AST Test Kits: May Exhibit Incorrect Ceftriaxone Concentrations https://alerts.ecri.org/alerts/view/details/1656644 4/16/2024 7:22:03 AM Abbott—Alinity m: May Have Problems with Third-Party Universal Transport Medium Tubes https://alerts.ecri.org/alerts/view/details/1656701 4/15/2024 6:26:19 PM Medline—Cardinal Health Jackson-Pratt Reservoir Kits: Sterility May Be Compromised https://alerts.ecri.org/alerts/view/details/1656688 4/15/2024 2:56:48 PM Medline—Sterile Convenience Kits: Pure Pouch Component May Have Weak Seal https://alerts.ecri.org/alerts/view/details/1656690 4/15/2024 2:53:03 PM Cencora—Avanos NEOMED* Non-Sterile Non-ENFit Oral Syringes: Expired Syringes May Have Been Shipped to Customers https://alerts.ecri.org/alerts/view/details/1656673 4/15/2024 1:49:37 PM FDA Is Evaluating the Potential for Device Failures with Plastic Syringes Manufactured in China [Update] https://alerts.ecri.org/alerts/view/details/1656693 4/15/2024 1:43:19 PM Medline—Endocavity Probe Covers: May Contain Undeclared Latex https://alerts.ecri.org/alerts/view/details/1656710 4/15/2024 11:54:10 AM Zimmer Biomet—12 x 75 mm Vanguard Knee System AS Tibial Bearings: May Be Damaged https://alerts.ecri.org/alerts/view/details/1656707 4/15/2024 11:25:24 AM Zimmer Biomet—Periarticular Locking Plate Systems and Distal Lateral Fibula Locking Plates: Locking Screws May Not Properly Mate with the Plate [MHRA FSN 29245045] https://alerts.ecri.org/alerts/view/details/1656706 4/15/2024 11:14:16 AM ZimVie—Biomet OrthoPak and SpinalPak Stimulator Systems: Lead Wire Sheath Component May Be Damaged, Causing Exposure of Wires https://alerts.ecri.org/alerts/view/details/1656674 4/12/2024 1:58:05 PM GE HealthCare—Medtronic SpO2 Nellcor Cables Branded as GE Apex Pro CH/FH SpO2 Nellcor Cables: May Transfer SpO2 Data to ApexPro CH and FH Telemetry Systems as "X" without Providing Appropriate Alarm Notification https://alerts.ecri.org/alerts/view/details/1656662 4/12/2024 1:48:22 PM Synovo—Total Hip Resurfacing Systems: FDA Recommends against Use [Update] https://alerts.ecri.org/alerts/view/details/1656650 4/12/2024 12:54:11 PM ConvaTec—CarboFlex 8 x 15 cm and 15 x 20 cm Odor Control Dressings: Sterility May Be Compromised https://alerts.ecri.org/alerts/view/details/1656645 4/12/2024 10:47:38 AM McKesson Medical-Surgical—Cardinal Health Monoject Hypodermic Safety Needle with Syringe Combination Products: Manufacturer Implements Product Hold in Response to FDA Advisory Regarding Syringes Manufactured in China https://alerts.ecri.org/alerts/view/details/1656661 4/12/2024 10:39:25 AM Smiths—Medfusion Model 3500 and Model 4000 Syringe Infusion Pumps: Manufacturer Recommends against Use of Cardinal Health Branded Monoject Syringes [MHRA FSN 29242780] https://alerts.ecri.org/alerts/view/details/1656689 4/12/2024 9:35:43 AM Green Power—Lithium-Ion Batteries: May Present Fire Risk [MHRA FSN 29242630] https://alerts.ecri.org/alerts/view/details/1656684 4/11/2024 3:28:30 PM Medtronic—HeartWare Ventricular Assist Device Systems: May Exhibit a Delay or Failure to Restart [Update] [MHRA FSN 29243508] https://alerts.ecri.org/alerts/view/details/1656686 4/11/2024 3:07:37 PM Cardinal Health—Monoject Hypodermic Safety Needle with Syringe Combination Products: Manufacturer Implements Product Hold in Response to FDA Advisory Regarding Syringes Manufactured in China https://alerts.ecri.org/alerts/view/details/1656660 4/11/2024 2:49:35 PM Medline—Micro-Kill Bleach Germicidal Wipes: Products Dated with 24-Month Shelf Life May Exhibit Stability Problems [Update] https://alerts.ecri.org/alerts/view/details/1656655 4/11/2024 2:41:41 PM Merit—Prelude Roadster Guide Sheaths: May Include Incorrect Dilator https://alerts.ecri.org/alerts/view/details/1656637 4/11/2024 2:38:18 PM Cook—EchoTip Ultra High Definition Ultrasound Access Needles and EchoTip Ultra Endoscopic Ultrasound Needles: Bacterial Endotoxin Levels May Be Out of Specification [MHRA FSN 29239345] https://alerts.ecri.org/alerts/view/details/1656680 4/11/2024 2:13:14 PM Abbott—Aveir VR Leadless Pacemakers: Electromagnetic Interference May Cause Mode Change [MHRA FSN 29240940] https://alerts.ecri.org/alerts/view/details/1656682 4/11/2024 2:07:44 PM Stryker—Triathlon TS Plus Tibial Inserts X3 Poly and X3 Triathlon CS Inserts: Packaging May Be Breached [Update] https://alerts.ecri.org/alerts/view/details/1656652 4/11/2024 1:58:48 PM Cardinal Health—Avanos NEOMED* Non-Sterile Non-ENFit Oral Syringes: Expired Syringes May Have Been Shipped to Customers https://alerts.ecri.org/alerts/view/details/1656671 4/11/2024 1:41:09 PM Siemens—Calibration Verification Material Used with RAPIDPoint 500/500e Blood Gas Systems: Instructions for Use May Include Incorrect Performance Variability Ranges and Be Missing Alternative Units https://alerts.ecri.org/alerts/view/details/1656669 4/11/2024 1:23:08 PM Baxter—CLEARLINK Non-DEHP Solution Sets with Luer Lock Adapter: May Leak from Drip Chamber https://alerts.ecri.org/alerts/view/details/1656664 4/11/2024 12:47:39 PM Baxter—OT 1000 Boot Assembly Traction Devices: Locking Pin May Be Incorrectly Oriented https://alerts.ecri.org/alerts/view/details/1656672 4/11/2024 12:18:09 PM Honeywell—Eyesaline Emergency Eyewashes: May Have Deviated from Current Good Manufacturing Practices https://alerts.ecri.org/alerts/view/details/1656622 4/11/2024 8:27:15 AM