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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex
AUDIENCE: Consumer, Health Professional, Patient
ISSUE: CDC reports that there are 10 confirmed cases of infection caused by bacteria within the Burkholderia cepacia complex, also commonly called B. cepacia, in three states: California (2), Pennsylvania (7), and New Jersey (1). These patients were already hospitalized for acute conditions and acquired the infections while hospitalized. The infections have been linked to the Medline product, Remedy Essentials No-Rinse Cleansing Foam.
BACKGROUND: On March 28, 2018, Shadow Holdings dba Bocchi Laboratories of Santa Clarita, CA, announced a voluntary recall of 4oz and 8oz bottles of Medline Remedy Essentials No-Rinse Cleansing Foam lots that had been identified as positive for B. cepacia.
Samples of the product that were collected by FDA from a hospital and distribution center tested positive for B. cepacia; isolates from these samples match clinical isolates collected from ill persons by Pulsed Field Gel Electrophoresis (PFGE), a type of DNA fingerprinting. Additionally, an environmental swab collected at Shadow Holdings, dba Bocchi Laboratories during FDA’s investigation has tested positive for a strain of B. cepacia. The FDA is currently investigating this matter further to determine whether any additional products or lots may present a risk to consumers.
RECOMMENDATION: The FDA is advising health professionals and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing Foam at this time. The following item and lot numbers were voluntarily recalled by Shadow Holdings dba Bocchi Laboratories on March 28, 2018: 4oz Item number MSC092FBC04; lots M06691, M07247; 8oz Item number MSC092FBC08; lots M05703 and M06691, as these products may be contaminated with the bacteria B. cepacia and there is a potential for severe patient infection. Given this is an ongoing investigation, additional products from Shadow Holdings dba Bocchi Laboratories might be contaminated as well.
Any hospital or company that purchased Medline Remedy Essentials No-Rinse Cleansing Foam should immediately quarantine material under their control and contact Shadow Holdings dba Bocchi Laboratories. Patients, pharmacies, home health care facilities, hospitals and all health care facilities should immediately stop using and dispensing Medline Remedy Essentials No-Rinse Cleansing Foam.
Healthcare facilities should follow the recall instructions for the recalled lots and avoid the use of all other lots of the product while further investigation is being conducted. Evaluation of additional lots is ongoing. In the interim, hospital and healthcare facilities should avoid using all other lots of this product, particularly in patients at greater risk for B. cepacia infection, until further information is available.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert at:https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm607371.htm
Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design
AUDIENCE: Emergency Medicine, Health Professional, Risk Manager, Patient, Pulmonology
ISSUE: Vyaire Medical is recalling the AirLife Resuscitation Device & Broselow Convenience Kit due to an error in its product design that may result in difficultly or the inability to disconnect the mask from the elbow of the resuscitator.
The AirLife Resuscitation Device & Broselow Convenience Kit comes fully assembled and ready to use with a cushioned mask, which can be removed to provide continuous ventilation after placement of an advanced airway device. However, the cushioned mask component has the possibility of sticking to the elbow of the resuscitator, making removal of the mask difficult, or unattainable. Difficulty disconnecting the mask from the resuscitator could result in a delay in or inability to provide necessary ventilation to the patient and potentially result in serious patient injury, such as hypoxia (inadequate oxygen supply), or death.
BACKGROUND: The Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit are manual resuscitation devices used together as one pair to provide constant ventilation to adults and children who are not breathing or cannot adequately breathe on their own following placement of an advanced airway device (tracheal or tracheostomy tube).
The AirLife Resuscitation Device & Broselow Convenience Kit are used in hospitals and other acute health care settings under the supervision of doctors and other trained health care providers.
RECOMMENDATION: Vyaire Medical sent an initial Urgent Recall Notification letter on April 27, 2017, and an updated letter on June 8, 2017 instructing customers to:
- Inspect inventory on-hand and remove affected lots of the AirLife Resuscitation Device & Broselow Convenience Kit
- Destroy all affected product(s) in-stock in accordance with their facility's destruction protocol
- Complete the enclosed Customer Response Form and return to GMB-GLB-VSFieldActions@CareFusion.com
- Contact Vyaire Medical Customer Support at (800)-323-9088 (Option #1), Monday-Friday, 8 AM – 5 PM (CST) if they wish to obtain replacement devices.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert at:https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm607494.htm
WASHINGTON—U.S. Citizenship and Immigration Services (USCIS) today posted a policy memorandumchanging how the agency will calculate unlawful presence for students and exchange visitors in F, J, and M nonimmigrant status, including F-2, J-2, or M-2 dependents, who fail to maintain their status in the United States.
“USCIS is dedicated to our mission of ensuring the integrity of the immigration system. F, J, and M nonimmigrants are admitted to the United States for a specific purpose, and when that purpose has ended, we expect them to depart, or to obtain another, lawful immigration status,” said USCIS Director L. Francis Cissna. “The message is clear: These nonimmigrants cannot overstay their periods of admission or violate the terms of admission and stay illegally in the U.S. anymore.”
Individuals in F, J, and M status who failed to maintain their status before Aug. 9, 2018, will start accruing unlawful presence on that date based on that failure, unless they had already started accruing unlawful presence, on the earliest of any of the following:
- The day after DHS denied the request for an immigration benefit, if DHS made a formal finding that the individual violated his or her nonimmigrant status while adjudicating a request for another immigration benefit;
- The day after their I-94 expired; or
- The day after an immigration judge or in certain cases, the Board of Immigration Appeals (BIA), ordered them excluded, deported, or removed (whether or not the decision is appealed).
Individuals in F, J, or M status who fail to maintain their status on or after Aug. 9, 2018, will start accruing unlawful presence on the earliest of any of the following:
- The day after they no longer pursue the course of study or the authorized activity, or the day after they engage in an unauthorized activity;
- The day after completing the course of study or program, including any authorized practical training plus any authorized grace period;
- The day after the I-94 expires; or
- The day after an immigration judge, or in certain cases, the BIA, orders them excluded, deported, or removed (whether or not the decision is appealed).
Individuals who have accrued more than 180 days of unlawful presence during a single stay, and then depart, may be subject to three-year or 10-year bars to admission, depending on how much unlawful presence they accrued before they departed the United States. Individuals who have accrued a total period of more than one year of unlawful presence, whether in a single stay or during multiple stays in the United States, and who then reenter or attempt to reenter the United States without being admitted or paroled are permanently inadmissible.
Those subject to the three-year, 10-year, or permanent unlawful presence bars to admission are generally not eligible to apply for a visa, admission, or adjustment of status to permanent residence unless they are eligible for a waiver of inadmissibility or another form of relief.
This policy memorandum is updating Chapter 40.9.2 of the USCIS Adjudicator’s Field Manual.
USCIS is accepting comments on the policy memorandum. The 30-day public comment period begins today and closes on June 11, 2018. For complete information on the comment process, visit the Policy Memoranda for Comment page.
For more information on USCIS and its programs, please visit uscis.gov or follow us on Twitter (@uscis), YouTube (/uscis), and Facebook (/uscis).
- USCIS –
WASHINGTON— U.S. Citizenship and Immigration Services (USCIS) and the Department of Justice today announced a Memorandum of Understanding (MOU) that expands their collaboration to better detect and eliminate fraud, abuse, and discrimination by employers bringing foreign visa workers to the United States. This new effort improves the way the agencies share information, collaborate on cases, and train each other’s investigators.
The MOU will increase the ability of the agencies to share information and help identify, investigate, and prosecute employers who may be discriminating against U.S. workers and/or violating immigration laws. In 2010, USCIS and the Justice Department’s Civil Rights Division entered into an ongoing partnership to share information about E-Verify misuse and combat employment discrimination, and today’s MOU expands upon the two agencies’ existing partnership.
In 2017, the Civil Rights Division launched the Protecting U.S. Workers Initiative, which is aimed at targeting, investigating, and taking enforcement actions against companies that discriminate against U.S. workers in favor of foreign visa workers. Under this Initiative, the Civil Rights Division has opened dozens of investigations, filed one lawsuit, and reached settlement agreements with two employers. Since the Initiative’s inception,employers have agreed to pay or have distributed over $200,000 in back pay to affected U.S. workers. The Division has also increased its collaboration with other federal agencies to combat discrimination and abuse by employers using foreign visa workers.
USCIS administers the nation’s immigration system and adjudicates requests for immigration benefits, including employment-based petitions. To advance the goals of the Buy American and Hire American Executive Order and promote the economic interests of U.S. workers, USCIS is taking concrete steps to ensure the integrity of the employment-based immigration programs and improve its ability to detect and prevent fraud. Among other things, USCIS has created dedicated tip lines for reporting H-1B and H-2B visa fraud and abuse, and expanded its site visit programs. USCIS has also worked with other government agencies that have a role in immigration, such as DOJ, to ensure that they efficiently share and appropriately act upon information regarding potential fraud and abuse of immigration programs. For more information, visit the USCIS Buy American and Hire American page.
“In the spirit of President Trump’s Executive Order on Buy American and Hire American, today’s partnership adds to the Civil Rights Division’s tools to stop employers from discriminating against U.S. workers by favoring foreign visa workers,” said Acting Assistant Attorney General John M. Gore of the Civil Rights Division. “The Division looks forward to expanding its partnerships with USCIS to hold accountable employers that discriminate against U.S. workers based on their citizenship status.”
“Protecting and maintaining the integrity of our immigration system remains a key priority for me, and underpins the exceptional work of the professionals at USCIS,” said USCIS Director L. Francis Cissna. “This agreement enhances the level of coordination among investigators who often work on the same issues at different agencies. Breaking down silos and working with our federal partners to combat employment discrimination will help ensure that U.S. workers have the advocate they need at the highest level.”
For more information about protections against employment discrimination under immigration laws, call IER’s worker hotline at 1-800-255-7688 (1-800-237-2515, TTY for hearing impaired); call IER’s employer hotline at 1-800-255-8155 (1-800-237-2515, TTY for hearing impaired); sign up for a free webinar; email IER@usdoj.gov; or visit IER’s English and Spanish websites. Applicants or employees who believe they were subjected to retaliation; different documentary requirements based on their citizenship, immigration status or national origin; or discrimination based on their citizenship, immigration status, or national origin in hiring, firing, or recruitment or referral for a fee, should contact IER’s worker hotline for assistance.
For more information on USCIS and its programs, please visituscis.gov or follow us on Twitter (@uscis), Instagram (/uscis), YouTube (/uscis), and Facebook(/uscis).
- USCIS -
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