Picket Fence Creamery L.L.C. Recalls

Undeclared soy lecithin.

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

Cow Path Ice Cream (Picket Fence) – undeclared peanuts (2021)

Undeclared Nuts

Undeclared peanuts, label declares nuts.

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

Valproic Acid Oral Solution (American Health) – Microbial Contamination (2021)

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

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Class II

Moderate

FDASep 15, 2021Nationwide• American Health Packaging

S'mores! Ice Cream (Picket Fence) – undeclared soy (2021)

Undeclared soy lecithin.

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

Mocha! Ice Cream (Picket Fence) – undeclared soy (2021)

Undeclared soy lecithin.

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

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

Undeclared soy lecithin.

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

Dutch Letter! Ice Cream (Picket Fence) – undeclared almonds (2021)

Undeclared Allergen

Undeclared almonds, label declares nuts.

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

CowaBrownie! Ice Cream (Picket Fence) – undeclared soy (2021)

Undeclared soy lecithin.

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

Bacon-Ranch White Cheddar Cheese Curds (Picket Fence Creamery) – Undeclared Soy (2021)

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.

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.

Elekta Monaco (Elekta) – Contour Changes Risk (2021)

Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.

Moderate

FDASep 14, 2021Nationwide• Elekta Inc

Trail King AACS (Trail King) – Suspension Beam Issue (2021)

Trail King Industries, Inc. (Trail King) is recalling certain 2019 TK80ACS and TK80AACS trailers. The rear sliding axle suspension beams may contact a frame reinforcement, causing cracking in the suspension beam.

NHTSASep 14, 2021Nationwide• TRAIL KING

Kaufman Equipment Trailer (Kaufman) – Incorrect Locking Mechanism (2021)

Kaufman Trailers of NC, Inc. (Kaufman Trailers) is recalling certain 2021 Equipment trailers. These trailers have an incorrect internal locking mechanism, and when coupled with a 2-5/16" ball hitch may result in excessive play and trailer detachment.

NHTSASep 14, 2021Nationwide• KAUFMAN

Keystone Bullet (Keystone) – LPG System Problem (2021)

Fire/Burn Risk

Keystone RV Company (Keystone) is recalling certain 2019-2021 Dutchmen Aspen Trail, Coleman, Keystone Cougar, Bullet, Passport, Hideout, Springdale, Sprinter, 2019 Keystone Impact, Fuzion, Residence, Retreat, Summerland, and Dutchmen Kodiak recreational vehicles, equipped with Winntec model 6020 two-stage propane regulators. The regulator may fail, causing an increase in propane pressure.

NHTSASep 13, 2021Nationwide• KEYSTONE

FIVE S Intubation Videoscope (Karl Storz) – Sterility Assurance Risk (2021)

During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.