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Showing 11101–11120 of 11714 results

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Smooth & Creamy Take the Cake Ice Cream (Harris Teeter) – undeclared soy (2019)

The firm discovered that the allergen soy was not declared in the ingredient statement or allergen declaration.

Class IIModerate

FDAOct 17, 2019AL, NC, VA• Harris Teeter Supermarkets, LLC dba Hunter Farms

Harris Teeter Chocolate Ice Cream – Undeclared Soy (2019)

The firm discovered that the allergen soy was not declared in the ingredient statement or allergen declaration.

Class IIModerate

FDAOct 17, 2019AL, NC, VA• Harris Teeter Supermarkets, LLC dba Hunter Farms

Fresh Market Mint Chip Ice Cream (Harris Teeter) – undeclared soy (2019)

The firm discovered that the allergen soy was not declared in the ingredient statement or allergen declaration.

Class IIModerate

FDAOct 17, 2019AL, NC, VA• Harris Teeter Supermarkets, LLC dba Hunter Farms

Mint Chocolate Chip Ice Cream (Harris Teeter) – undeclared soy (2019)

The firm discovered that the allergen soy was not declared in the ingredient statement or allergen declaration.

Class IIModerate

FDAOct 17, 2019AL, NC, VA• Harris Teeter Supermarkets, LLC dba Hunter Farms

TELEFLEX MEDICAL INC: Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distr...

Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.

FDAOct 11, 2019Nationwide• TELEFLEX MEDICAL INC

TELEFLEX MEDICAL INC: Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distr...

Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.

FDAOct 11, 2019Nationwide• TELEFLEX MEDICAL INC

Hologic, Inc: Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, ...

Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.

FDAOct 10, 2019AR, CA, FL +11 more• Hologic, Inc

Draegar Medical Systems, Inc.: Infinity M300 telemetry monitoring device Software versio...

The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.

FDAOct 9, 2019Nationwide• Draegar Medical Systems, Inc.

Signature Orthopaedics Europe Ltd Unit A, IDA Business & Technology Park Garrycastle Athlone Ireland: Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 1...

The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included in the packaging resulting in a surgical delay.

FDAOct 9, 2019CA• Signature Orthopaedics Europe Ltd Unit A, IDA Business & Technology Park Garrycastle Athlone Ireland

Teleflex Medical: Arrow EZ-IO Intraosseous Vascular Access System 15mm Need...

The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

FDAOct 8, 2019Nationwide• Teleflex Medical

Nova Ortho-Med Inc: Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ B...

Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker.

FDAOct 7, 2019AK, AZ, AR +35 more• Nova Ortho-Med Inc

Teleflex Medical: WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE0...

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

FDAOct 4, 2019Nationwide• Teleflex Medical

Teleflex Medical: WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-...

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

FDAOct 4, 2019Nationwide• Teleflex Medical

Baxter Healthcare Corporation: Prismaflex Control Unit, software versions below 7.21

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

FDAOct 4, 2019Nationwide• Baxter Healthcare Corporation

Nana's Been a Nut Bread (Gullah Gourmet) – Unlisted Ingredient (2019)

The product ingredient statement does not list walnuts in the product.

Class IIModerate

FDAOct 4, 2019AL, FL, GA +13 more• Gullah Gourmet, Inc.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Programmers & Remote Monitoring Software Apps: 2090 Care...

There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.

FDAOct 3, 2019Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Monarch Medical Technologies: EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

Product was distributed prior to approval or clearance from FDA.

FDAOct 1, 2019CA, IL, IN +1 more• Monarch Medical Technologies

Energetiq Technology Inc: EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage:...

On September 27, 2019 Energetiq Technology (the manufacturer) discovered a problem with their EQ-400-RH-QZ and EQ-400-LH-BK products during routine manufacturing functional testing. It was noted that a safety interlock within the lamp does not function in a reliable manner to shut down the system if the laser collimator is removed from the lamp while the system is operating. This is a potential safety hazard for anyone working on or nearby the lamp.

FDASep 27, 2019Nationwide• Energetiq Technology Inc

Elekta Impac Software: MOSAIQ, oncology information system - Product Usage: MOSA...

The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.

FDASep 24, 2019Nationwide• Elekta Impac Software

Tomtec Imaging Systems Gmbh Edisonstr. 6 Unterschleisheim Germany: TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Pi...

The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might be stored to another study.

FDASep 23, 2019AL, AZ, CA +12 more• Tomtec Imaging Systems Gmbh Edisonstr. 6 Unterschleisheim Germany

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