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Friday, January 10, 2020

RECALLS

Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator
Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.

The company is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed. This is a result of oxidation that may have formed over time within the “Shock” button.

The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad. Stryker anticipates that all devices subject to this field action will be serviced by June 2021.

Most complaints associated with this issue were detected prior to patient use. Routine testing of the device can detect this fault condition. If a customer experiences this issue, they should contact Stryker as soon as possible at 1-800-787-9537 and select option 2.

The company is instructing customers to continue to use their LIFEPAK 15 monitor/defibrillator according to the Operating Instructions until the correction can be completed. Customers should continue to perform the daily check as described in the Operator’s Checklist, specifically, the QUIK- COMBO therapy cable check as described in the General Maintenance and Testing Section (pages 10-4 and the LIFEPAK 15 monitor/defibrillator Operator’s Checklist, number 7).


Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot of Lamotrigine 100 mg Tablets Lot #331771 (expiration date June 2021) was found to have been cross-contaminated with a small amount of another drug substance (Enalapril Maleate) used to manufacture another product at the same facility.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200110005522/en/
External Link Disclaimer

Risk Statement: Use of Lamotrigine 100 mg Tablets could potentially result in exposure to a small amount of Enalapril Maleate, if present in the product in question. Enalapril Maleate is a drug substance indicated for hypertension and congestive heart failure. There is potential with chronic exposure to Enalapril Maleate to impact users particularly if they are small children or pregnant women. Enalapril Maleate is also associated with risk of birth defects in a developing fetus. Therefore, there is risk associated with the continued, long-term use of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021).

Culinary International, LLC Recalls Chicken Burrito Products Due to Misbranding and Undeclared Allergens

Culinary International, LLC, a Vernon, Calif. establishment, is recalling approximately 626 pounds of egg burrito products labeled as chicken burrito products due to misbranding and undeclared allergens.

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