2021 Product Recalls

Software May Cause Unintentional Vehicle Movement

Unintentional vehicle movement can increase the risk of a crash.

Dealers will update the electronic stability program control unit software, free of charge. Owner notification letters were mailed February 11, 2022. Owners may contact DVUSA customer service at 1-877-762-8267. DVUSA's number for this recall is VS3PA27 ERI/ERO.

Fuel Tubes May Crack and Leak Fuel

A high pressure fuel leak in the presence of an ignition source can increase the risk of a fire.

On engines with 75 miles or less, Cummins dealers will install vibration isolators to the fuel tubes. Engines with more than 75 miles will receive new fuel tubes with vibration isolators. Repairs will be performed free of charge. Owner notification letters were mailed March 11, 2022. Owners may contact MCI customer service at 1-800-241-2947. MCI's number for this recall is R21-028.

Panoramic Roof Panel May Separate from Vehicle

Panoramic roof panel separation while driving can increase the risk of an injury or crash.

Dealers will remove, clean, and reinstall the panoramic roof panel, free of charge. This recall is an expansion of NHTSA recall number 16V-695. Owner notification letters were mailed January 21, 2022. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 16S35.

Alaura Two-Tone Jar Candles Recalled for Fire Hazard

The recalled jar candles can shatter, crack or break apart while burning, posing laceration and fire hazards.

Consumers should immediately stop using the recalled candle and return it to any Costco Warehouse for a full refund. Consumers who are not able to return the candle to a Costco Warehouse can contact Northern Lights by email at cr@northernlightscandles.com for instructions on how to cut the candle wicks, provide verification of this to Northern Lights, and then dispose of the candle to receive a full refund. Costco is contacting all known purchasers directly.

Infant Bath Seats Recalled for Drowning Hazard

The bath seats fail to meet the federal safety standard for infant bath seats, including requirements for stability and leg openings, and can tip over while in use, posing a drowning hazard to babies.

Consumers should immediately stop using the recalled infant bath seats and contact Karmas Far to receive a pre-paid label to return the products. Upon receipt of the products, consumers will be issued a full refund for the purchase price. Karmas Far is notifying all known purchasers directly.

Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.

Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.

On 11/19/2021, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers and followed up with a hardcopy letter on 11/30/2021 via US Postal Service, to inform them that the firm failed to register with the U.S. Food and Drug Administration and therefore must be recalled from the market, and the risk of using the affected products can result in Inaccurate force measurements may result from using these devices. If inaccurate measurements are used to judge rehabilitation progress, the most immediate consequence is an increased risk of re-injury to the patient. Customers are instructed to: 1. Cease all use of these devices immediately. Use alternative methods and tools, such as manual muscle testing to measure force and/or a goniometer to measure range of motion. 2. Fill out the RECALL RETURN RESPONSE form. 3. Return the RECALL RETURN RESPONSE form and all devices in their possession to the Recalling Firm using the included pre-paid envelope. Customers only need to return the handheld dynamometer unit. Do not return the case, packaging or any accessories. For questions, contact support team via support@activbody.com

Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system

Base plate may detach from the main body of the treatment applicator.

The firm notified their consignees by email on 08/27/2021. The notice requested the following actions be taken: Xstrahl Limited are issuing the following inspection advice for all X150 specifical system users. 1. Prior to any clinical exposure the operator of the system should inspect the treatment applicator prior to inserting it into the treatment head of the X150. 2. As part of the daily assurance process the treatment applicators should be inspected. 3. If a treatment applicator is dropped it should be inspected by medical physics to ensure it is not damaged. 4. If the base plate is missing the applicators must be withdrawn from clinical use until it is repaired and accepted by medical physics. 5. In the case of an applicator where the base plate has become detached, review the prescription history for the patients for whom that applicator was prescribed. 6. Please advise Xstrahl Limited if you believe patients have been treated with a base plate missing, with detail of the applicator size and clinical filter, kV and HVL, and we will contact you directly.

Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."

On 09-Nov-2021, Medtronic initiated mailing the patient letter, including a corrected Medical Device Identification Card, to impacted patients. In addition, on 08-Nov-2021, physicians following impacted patients were sent a physician letter explaining the correction.

da Vinci SP surgical system

Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.

The firm sent a letter to consignees on April 1, 2020 stating that an Intuitive representative will schedule a site visit to provide a software update as soon as possible. Firm representatives will be available by phone to answer any questions related to this Medical Device Correction. Actions taken by the customer are to: Inform all personnel who are involved with the affected device at your site of the following instructions: 1.If vibrations are sensed at the instrument and/or endoscope tips in Adjust Mode and the instrument arm is near its vertical limit: a.Cease applying sustained force against the hand control haptic feedback, b.Exit Adjust Mode by releasing the Endoscope Control pedal c.Exit following mode by removing your head from the Surgeon Console, or d.Press the Emergency Stop button. Any of these actions will stop the vibration. 2.If mechanical vibration persists, discontinue use of the system and contact Technical Support. 3.Inform affected personnel when the software update has been completed by the Intuitive representative. 4.Complete the attached Acknowledgment Form and return it via fax or email to Intuitive as instructed on the form. 5.Please retain a copy of this letter and the acknowledgment form for your files. Customers with additional questions: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST); South Korea: + 82-02-3271-3200, Opt. 3 (9 AM to 6 PM KSTJ)

Electronic Control Center Circuit Board May Short

Damaged components may overheat, increasing the risk of a fire.

Dealers will install an additional circuit module to the existing component board, free of charge. Owner notification letters were mailed February 9, 2022. Owners may contact TOURIG at 1-303-710-2914.

Fuel Tubes May Crack and Leak Fuel

A high pressure fuel leak in the presence of an ignition source can increase the risk of a fire.

On engines with 75 miles or less, dealers will install vibration isolators to the fuel tubes. Engines with more than 75 miles will receive new fuel tubes with vibration isolators. Repairs will be performed free of charge. Owner notification letters were mailed December 22, 2021. Owners may contact Cummins Care at 1-800-CUMMINS (1-800-286-6467) or visit the website at care.cummins.com or owners may contact Shyft Group customer service at 1-800-582-3454. Shyft Group's number for this recall is 21-23.

12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.

Failed dissolution specifications

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.

Product Mix-up

Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.

Failed dissolution specifications

Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.

Failed dissolution specifications

Schwinn Tone Electric Scooters (e-scooters) Recalled for Fall Hazard

The e-scooter's handlebar grips can loosen or crack, posing fall and injury hazards.

Consumers should immediately stop using the recalled e-scooters and contact Pacific Cycle for a free repair kit. Consumers will need to provide the serial number of their scooter and a mailing address. The repair kit can be installed by the consumer and includes all required tools and instructions, which are also available in video format. Pacific Cycle estimates it will take consumers between five and ten minutes to install. Alternatively, consumers can ship the e-scooter back to Pacific Cycle for repair, at no cost to the consumer.

Hisun 250cc Utility Vehicles Recalled for Fire Hazard

Grass can accumulate on the under-side of the utility vehicle near the exhaust pipe, posing a fire hazard.

Consumers should immediately stop using the recalled utility vehicles and contact Hisun U.S.A. for a free consumer installable repair kit or arrange to take the utility vehicle to an approved service center for a free repair.

Harbor Breeze Belleisle Bay and Honeywell Rio Ceiling F Recalled for Injury Hazard

The blades can detach from the fan while in use, posing an impact injury hazard to consumers.

Consumers should immediately stop using the recalled fans and contact Hong Kong China Electric Appliance Manufacture Company ("HKC") to confirm their fan is under the scope of the recall by providing the firm a photo of the fan and date code. The consumers will then be instructed to disconnect the fan, provide a photo of the disconnected fan to HKC and dispose of it in the trash or recycle. The consumer will then receive a free replacement fan by mail.

VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25

Crystallization: Product appears to be turbid.

AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.