Picket Fence Creamery L.L.C. Recalls

Undeclared soy lecithin

FDASep 15, 2021IN, IA• Picket Fence Creamery L.L.C.

Key Lime Pie Ice Cream (Picket Fence Creamery) – Undeclared Wheat (2021)

Undeclared Gluten

Undeclared wheat, no gluten free labeling, and soy lecithin.

FDASep 15, 2021IN, IA• Picket Fence Creamery L.L.C.

Chocolate Malt Ice Cream (Picket Fence) – undeclared soy (2021)

Undeclared soy lecithin.

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Class IIModerate

FDASep 15, 2021IN, IA• Picket Fence Creamery L.L.C.

Luscious Lemon Ice Cream (Picket Fence) – undeclared soy (2021)

Undeclared soy lecithin.

FDASep 15, 2021IN, IA• Picket Fence Creamery L.L.C.

White Chocolate Raspberry Ice Cream (Picket Fence) – undeclared soy (2021)

Undeclared soy lecithin.

FDASep 15, 2021IN, IA• Picket Fence Creamery L.L.C.

Jalapeno-Ranch White Cheddar Cheese Curds (Picket Fence) – undeclared soy (2021)

Undeclared soy lecithin.

FDASep 15, 2021IN, IA• Picket Fence Creamery L.L.C.

Taco White Cheddar Cheese Curds (Picket Fence) – undeclared wheat (2021)

Undeclared Gluten

Undeclared wheat, no gluten free labeling.

FDASep 15, 2021IN, IA• Picket Fence Creamery L.L.C.

Medtronic Bio-Medicus Insertion Kits (Medtronic) – Label Mix-up (2021)

There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

FDASep 13, 2021Nationwide• Medtronic Perfusion Systems

Anise Almond Biscotti (Enrico Biscotti) – Undeclared Soy (2021)

Undeclared soy

FDASep 13, 2021IN, NY, OH• The Enrico Biscotti Company

Cranberry Pistachio Biscotti (Enrico Biscotti) – Undeclared Soy (2021)

Undeclared soy

FDASep 13, 2021IN, NY, OH• The Enrico Biscotti Company

TomoHelical Treatment Plans (RaySearch) – Jaw Position Error (2021)

If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning

FDASep 9, 2021Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

C315-HIS Delivery Catheter (Medtronic) – Lead Passage Issue (2021)

Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.

FDASep 9, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Ruzurgi Tablets (Jacobus) – Microbial Contamination (2021)

Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.

Class IHigh

FDASep 9, 2021Nationwide• Jacobus Pharmaceutical Company Inc.

BD Nexiva Catheter (Becton Dickinson) – Packaging Sterility Issue (2021)

There is a breach in the product packaging that renders the product non-sterile.

High

FDASep 8, 2021Nationwide• Becton Dickinson Infusion Therapy Systems Inc.

Raspberry Fudge Cordial (Velvet) – Undeclared Allergen (2021)

Undeclared Allergen

Class IHigh

FDASep 6, 2021IN, KY, MI +3 more• Velvet Ice Cream Company

ELI 280 Electrocardiograph (Welch Allyn) – Workflow Malfunction (2021)

The devices malfunction under specific operator workflows.