The Coastal Companies DBA Hearn Kirkwood Recalls

Undeclared milk and soy

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Le Croissant Tuna Salad (Hearn Kirkwood) – undeclared milk/soy (2023)

Undeclared milk and soy

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Le Croissant Turkey & Cheddar (Hearn Kirkwood) – undeclared milk/soy (2023)

Undeclared milk and soy

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Class IIModerate

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Breakfast Sandwich Bacon Egg & Cheddar (Hearn Kirkwood) – undeclared milk/soy (2023)

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Undeclared milk and soy

Class IIModerate

Le Croissant Ham & Swiss (Hearn Kirkwood) – undeclared milk/soy (2023)

FDANov 3, 2023AL, CT, DE +13 more• The Coastal Companies DBA Hearn Kirkwood

Undeclared milk and soy

Class IIModerate

Stratus Imaging PACS (Change Healthcare) – message association error (2023)

Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.

FDANov 1, 2023Nationwide• CHANGE HEALTHCARE CANADA COMPANY

Oasis Drain (Atrium) – premature aging (2023)

A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.

Moderate

FDANov 1, 2023Nationwide• Atrium Medical Corporation

Infusomat Administration Sets (B. Braun) – tubing inconsistency (2023)

In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.

FDANov 1, 2023Nationwide• B. Braun Medical, Inc.

Lubricating Eye Drops (Major) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

FDAOct 31, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lubricating Tears Eye Drops (Major) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

FDAOct 31, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Alinity HCV AMP Kit (Abbott) – false positive results (2023)

Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.

FDAOct 30, 2023Nationwide• Abbott Molecular, Inc.

Flexible Patient Circuit (Vyaire) – unapproved distribution (2023)

Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.

Low

FDAOct 27, 2023FL• Vyaire Medical

Phenytoin Sodium Capsules 100mg (Amneal) – failed dissolution (2023)

Failed Dissolution Specifications

Class IIModerate

FDAOct 27, 2023Nationwide• Amneal Pharmaceuticals of New York, LLC

Bobcat Zero-Turn Lawnmowers – crash risk (2023)

Laceration Risk

This recall involves Bobcat-branded and Kubota-branded stand-on zero-turn lawnmowers. The Bobcat stand-on zero-turn lawnmowers are black and white with the Bobcat name and logo on an orange background. They also have orange wheel wells. The Kubota stand-on zero-turn lawnmowers are orange and black with the Kubota name in white and orange wheel wells. The following model and serial numbers, located on the right side of the frame just above the operator platform, are included in this recall. The recalled engines are model year 2023 FR730V, FR691V, and FR651V. The recalled engine model and serial numbers are located on the engine fan housing. The following model and serial number ranges are included in this recall. Bobcat: MODEL SERIAL NUMBER ZS4036 999400100961 thru 999400100973 999400100975 thru 999400101046 999400101049 thru 999400101053 999400101055 ZS4036 SJAU 9994001AU80157 thru 9994001AU80165 9994001AU80168 thru 9994001AU80169 ZS4048 999400201096 thru 999400201170 ZS4048 SFAU 9994002AU00141 thru 9994002AU00145 ZS4052 999400301247 thru 999400301380 999400301382 thru 999400301385 999400301387 thru 999400301397 ZS4052 SKAU 9994003AU00125 ZS4061 999400400750 thru 999400400822 999400400826 thru 999400400831 999400400833 thru 999400400834 999400400836 thru 999400400838 ZS4061 SKAU 9994004AU00111 thru 9994004AU00112 Kubota: MODEL SERIAL NUMBER SZ19NC-36-2 14490 thru 14517 14618 thru 14620 14678 thru 14679 14803 thru 14818 14835 thru 14850 14856 thru 14857 14922 thru 14927 15051 thru 15062 SZ22NC-48-2 14380 14401 thru 14412 14566 thru 14568 14666 thru 14677 14695 thru 14700 14706 thru 14711 14790 thru 14796 14858 thru 14869 14928 thru 14931 15030 thru 15044 SZ26NC-52-2 14429 thru 14446 14466 thru 14471 14474 14484 thru 14489 14577 thru 14609 14692 thru 14694 14701 thru 14705 14712 thru 14717 14780 thru 14783 14872 thru 14888 14892 14921 14944 thru 14967 14992 thru 15007 SZ26NC-61-2 14417 thru 14425 14475 thru 14483 14622 thru 14643 14718 14763 thru 14771 14893 thru 14904 14971 thru 14991 15014 thru 15026 SZ19-36-2CAD 14558 thru 14565, 14801 SZ22-48-2CAD 14569 thru 14576, 14870 thru 14871, 15045 SZ26-61-2CAD 15009 thru 15013, 15029 1698562

CPSCOct 26, 2023Nationwide• Doosan Bobcat North America, of West Fargo, North Dakota

Kawasaki Lawn Mower Engines – fire risk (2023)

Fire/Burn Risk

This recall involves Kawasaki engines used in riding lawn mowers sold under the Ariens brand name with mower models IKON, IKON Onyx, and Apex, and under the Gravely brand name with mower models ZT X, ZT XL, ZT HD, and ZT HD Stealth, and under the Husqvarna brand name with mower models TS142TXD, TS242TXD, TS242XD, Z248F, and Z254F, and under the John Deere brand name with mower models Z330M and Z330R, and under the RedMax brand name with mower model RZT48. The recalled engines are model year 2023 FR730V, FR691V, and FR651V. The recalled engine model and serial numbers are located on the engine fan housing. The following model and serial number ranges are included in this recall. Engine Model Number Specification Number FR651V GS28 FR691V GS19 ES29 FR730V FS15 Engine Serial Number Range A full list of serial numbers included in this recall are on the firm's website at www.kawasakienginesusa.com/product-recall.html recall notice RP230415.

CPSCOct 26, 2023Nationwide• Kawasaki Motors Manufacturing Corp. U.S.A., of Maryville, Missouri

Mycophenolate Mofetil Suspension (VistaPharm) – defective container (2023)

Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.

Class IIILow

FDAOct 26, 2023Nationwide• VistaPharm LLC

CD11b APC (BD Biosciences) – cell staining quality (2023)

In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

FDAOct 25, 2023Nationwide• Becton, Dickinson and Company, BD Biosciences

INDICAID COVID-19 Test (Phase Scientific) – incorrect expiration (2023)

COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.

Low

FDAOct 25, 2023Nationwide• PHASE SCIENTIFIC INTERNATIONAL LIMITED 1/f, E Phase 3 Hong Kong Science Park Sha Tin Hong Kong SAR

Ultimate Presidential (Midwest Automotive) – wheel rim issue (2023)

Midwest Automotive Designs, LLC (Midwest) is recalling certain 2017-2022 Luxe Cruiser, Ultimate Club J, and Ultimate Presidential motorhomes. The alloy wheels installed on the vehicles are insufficient for the vehicle weight, which can cause the wheels to crack and fail.

NHTSAOct 23, 2023Nationwide• MIDWEST AUTOMOTIVE DESIGN

Intera 1.5T Power/Pulsar (Philips) – fire potential (2023)

Fire/Burn Risk

Potential component failure in the Gradient Coil could product smoke and/or fire.