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Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.

Limited official informationPatient-Relevant Medical Devices

Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System

Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where en...

AffectedAvanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection Sys...
RiskSupplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

AffectedBD Pyxis MedBank Tower REF: 1145-00 Medication cabinet; BD Pyxis Mini Main REF: 349 Medication cabinet; plus 6 additi...
RiskFingerprint scanner may overheat to a temperature to cause 1st degree burn.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality d...

AffectedBD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextros...
RiskThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextro...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Descript...

B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.

AffectedBrand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version:...
RiskB. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, th...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Prefac...

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

AffectedBrand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product...
RiskDue to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software V...

Due to incorrect shelf-life expiration date.

AffectedBrand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: C...
RiskDue to incorrect shelf-life expiration date.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050

Temperature probe devices lack FDA clearance.

AffectedCovidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050; Covidien Mon-a-Therm General Purpose Te...
RiskTemperature probe devices lack FDA clearance.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in prov...

Due to customer complaint regarding incorrect display box labeling.

AffectedCOVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are inte...
RiskDue to customer complaint regarding incorrect display box labeling.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marke...

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

AffectedDuloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC...
RiskCGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA...
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

Enoki Mushroom, Net Weight 150g

Imported Enoki Mushrooms samples collected by Florida Department of Health tested positive for Listeria Monocytogenes.

AffectedEnoki Mushroom, Net Weight 150g; Product of Korea; Distributed by IQ Produce UPC: 8809316 814286
RiskImported Enoki Mushrooms samples collected by Florida Department of Health tested positive for Listeria Monocytogenes.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.

Presence of foreign substance: small metallic particles in chewable tablets.

AffectedHALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, U...
RiskPresence of foreign substance: small metallic particles in chewable tablets.
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

Hellas Meze Golden Smoked Whole Herring

Un-eviscerated fish may be contaminated with clostridium botulinum

AffectedHellas Meze Golden Smoked Whole Herring
RiskUn-eviscerated fish may be contaminated with clostridium botulinum
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor,...

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

AffectedLidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia...
RiskLabeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

Lunds & Byerly's Curry Powder Sweet

Sesame Seeds White were labeled as Curry Powder Sweet.

AffectedLunds & Byerly's Curry Powder Sweet
RiskSesame Seeds White were labeled as Curry Powder Sweet.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

MAC 5 A4 Resting ECG Analysis System 855001-001

Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.

AffectedMAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
RiskSoftware in development inadvertently made available for customer use. Use of this software version can result in cli...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

Malazi 100% PURE SUDANESE SESAME Tahina G.W.: 1K.g UPC 6 224011 088244 Produced by: AL-MALAZ COMPANY FOR TRADE AND INDUSTRY Piece No. 110...

Salmonella. The firm was notified by the North Carolina Department of Agriculture that the product test positive for Salmonella.

AffectedMalazi 100% PURE SUDANESE SESAME Tahina G.W.: 1K.g UPC 6 224011 088244 Produced by: AL-MALAZ COMPANY FOR TRADE AND IN...
RiskSalmonella. The firm was notified by the North Carolina Department of Agriculture that the product test positive for...
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

Market of Choice Vegan Kale Caesar Salad, Net Wt. 9.5oz. Finished product is pre-packaged into a clear flexible plastic clamshell contain...

Undeclared allergen (sesame). Ingredients panel does not list sesame as sub-ingredient of Za'atar spice and Contains statement does not declare sesame.

AffectedMarket of Choice Vegan Kale Caesar Salad, Net Wt. 9.5oz. Finished product is pre-packaged into a clear flexible plast...
RiskUndeclared allergen (sesame). Ingredients panel does not list sesame as sub-ingredient of Za'atar spice and Contains...
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

My Wife's Slaw Jalapeno Heat, packaged in 8 oz. and 16 oz. glass mason jars with metal lids/bands, MyWifeslaw.web.app, Zanesville, Ohio....

Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified.

AffectedMy Wife's Slaw Jalapeno Heat, packaged in 8 oz. and 16 oz. glass mason jars with metal lids/bands, MyWifeslaw.web.app...
RiskProduct was manufactured and distributed without the benefit of an approved food establishment inspection and the req...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System

It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to th...

AffectedNeptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System
RiskIt has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136,...

Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

AffectedNiacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Phi...
RiskFailed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour tim...
ActionNot available

Missing from associated official evidence: action.