Plastikon Healthcare LLC Recalls

Acetaminophen Oral Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Calcium Carbonate Suspension (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

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Class II

Moderate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Acetaminophen Oral Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Acetaminophen Children's Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Magnesium Aluminum Simethicone MAX (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Diphenhydramine HCl Oral Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Guaifenesin Dextromethorphan Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Milk of Magnesia USP (Plastikon Healthcare) – Microbial Contamination (2022)

Microbial Contamination of Non-Sterile Products

Class IHigh

1st Phorm Protein Bar (Bakery Barn) – Foreign Material (2022)

Protein bar may be contaminated with plastic and paper foreign material

FDAJun 3, 2022IN, MO• Bakery Barn, LLC

Trevo Trak Microcatheter (Stryker) – Carton Label Omission (2022)

Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.

Low

FDAJun 3, 2022Nationwide• Stryker Neurovascular

Spinach Greek Yogurt Dip (Boar's Head) – Foreign Object (2022)

Foreign Object - plastic

FDAJun 3, 2022FL• Klondike Cheese Company

Backcountry Access Tracker4 Transceivers (Backcountry Access) – Loss Risk (2022)

This recall involves the Backcountry Access Tracker4 Avalanche Transceiver sold in yellow and black. The transceiver has a digital screen on the front and is about five inches long and three inches wide. "BCA" and the model name "Tracker4" are printed on the front of the unit. The serial number for a transceiver is located inside the battery compartment after removing the top AAA battery. Only the transceivers with serial numbers beginning with 21H05 or 21H06 are affected by this recall.

High

CPSCJun 2, 2022Nationwide• Backcountry Access, Inc.

GCX Channel Mounting Accessory (Skytron) – Mounting Screw Problem (2022)

Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom.

FDAJun 2, 2022Nationwide• Skytron, Div. The KMW Group, Inc

YelloPort Elite Universal Seal (Surgical Innovations) – Packaging Hole Risk (2022)

There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.

FDAJun 2, 2022Nationwide• Surgical Innovations Ltd Clayton House 6 Clayton Wood Rise Leeds United Kingdom

RayStation 9B SP1 (RaySearch) – Treatment Course Propagation Problem (2022)

An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.

FDAJun 1, 2022Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Cougar (Keystone) – Table/Bed Base Issue (2022)

Keystone RV Company (Keystone) is recalling certain 2022 Keystone Cougar travel trailers, equipped with a swing up table/bed base. The base may have incomplete welds that are unable to hold the intended weight, causing the table/bed base to drop unexpectedly.

High

NHTSAMay 27, 2022Nationwide• KEYSTONE

Pressure Monitoring Set (Cook) – Needle Coating Issue (2022)

The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.

FDAMay 25, 2022Nationwide• Cook Incorporated

Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip With... (Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233) – facility temperature excursions (from... (2022)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

FDAMay 25, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid... (Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233) – facility temperature excursions (from... (2022)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.