FDA approves first twice-yearly PrEP injection

Recalls and warnings

An early alert from Baxter stating that the Novum IQ large-volume pump (LVP) has a potential for underinfusion when transitioning to a higher flow rate. Additionally, Baxter has identified an increase in customer reports of over- and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. As of June 27, Baxter has reported 79 serious injuries and two deaths associated with this issue.

An early alert about updated instructions for use of Abiomed automated Impella controllers (AIC). During console-to-console transfer or case start, Abiomed Impella pumps may not be detected when connected to a controller. No visual alarm will indicate the detection issue in these situations. Three deaths have been reported to be associated with this issue.

A class I recall of select Newport HT70 and Newport HT70 Plus ventilators and certain related Newport service parts. Medtronic is advising discontinuation of clinical use of the affected devices. Investigation into customer complaints identified capacitors on the ventilator's controller printed circuit board assembly that may result in shutdown during use. The shutdown alert alarm may fail to sound effectively. There have been 63 reports associated with this issue, including two serious injuries and one death.

A recall of MedicaLyte liquid bicarbonate concentrate by Nipro after reports of visual irregularities in some product jugs, identified as bacterial and fungal particles. One serious injury and one death have been reported.

A class I recall of a mobile lift component by Baxter Healthcare Corporation because the Q-link 13 could allow for an improper attachment of the quick-release hook used on sling bars and other accessories. The false latched component may initially bear weight but can loosen from the Q-link, resulting in a detachment and drop that could injure patients and caregivers. Baxter has reported three serious injuries and one death associated with this issue.

A class I recall to correct Ethicon Endo-Surgery, LLC's, disposable surgical stapler cartridge to address inadvertent lockout during surgical procedures. The use of the affected product may cause serious adverse health consequences, including life-threatening hemorrhage, surgical delay, and death. There has been one reported death and one injury related to this issue.

A voluntary recall related to certain Alaris and BD Alaris pump modules that may have been serviced with previously recalled bezel kit assemblies. BD is issuing this voluntary recall notice to reiterate that certain bezel kit assemblies that were manufactured between April 2011 and June 2017 and previously recalled in 2019 should not be used for service with the Alaris and BD Alaris pump module. This recall has been associated with incidents of serious injury and patient death.

A class I recall of certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because a problem with the speaker may cause it to fail to make an alert sound when blood glucose is dangerously low or high. The use of affected product may cause serious adverse health consequences, including seizures, vomiting, loss of consciousness, and death. There have been at least 56 reported injuries.

A class I recall updating use instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH systems due to risk for bent or detached heater wires and silicone peeling or detaching during use. The use of affected product may cause serious adverse health consequences, including bleeding, burns, injury, or blockage of blood vessels, infection, and death. There have been seven reported serious injuries, four for the heater wire and three for silicone peeling or detaching.

A class I recall of an arterial cannula by Edwards Lifesciences due to risk of wire exposure. Specifically, Edwards Lifesciences has identified occurrences in which a 3-mm to 4-mm section of wire, from the wire-reinforcement coil at the cannula tip of the OptiSite arterial perfusion cannula devices, was found to be exposed. Risks to the patient of using the affected product with exposed wire include major tissue damage and puncturing the artery (which could cause bleeding, inadequate perfusion, and hemolysis). No serious injuries or deaths have been reported.

A class I recall of the iGo2 DV6X-619 DC car adapter, a non-critical accessory to the iGo2 portable oxygen concentrator, by Drive Devilbiss Healthcare, due to complaints of the DC power cord being hot to the touch and/or melting while being used. The use of affected product may cause serious adverse health consequences, including thermal injuries and/or burns to the fingers and/or hands. There have been two reported injuries.

A class I recall of MicroMyst applicators by Integra LifeSciences, due to incomplete bioburden assessments and incomplete sterilization location transfer documentation, both of which help ensure the products were effectively sterilized. The use of affected product may cause serious adverse health consequences, including inflammation, infection, and death. Integra LifeSciences has not reported any serious injuries or deaths associated with this issue.

A class I recall of adult manual resuscitator devices by SunMed Holdings, LLC, due to incorrect assembly of the B/V filter. The use of affected product may cause serious adverse health consequences, including lack of oxygen to the body, buildup of carbon dioxide in the blood, organ failure, and death. There have been no reported injuries.

A recall of all lots within expiry of sucralfate tablets USP, 1 g, manufactured after June 2023 by Nostrum Laboratories, Inc., following its bankruptcy and discontinuation of quality activities. No other Nostrum Labs products are affected by this recall.

A voluntary nationwide recall expansion of one additional lot of cefazolin for injection, USP, 1 g per vial by Sandoz, Inc., due to a customer complaint indicating that four vials incorrectly labelled as penicillin G potassium for injection, USP, 20 million units were included in cartons (25 vials per carton) of cefazolin for injection, USP 1 g per vial product. Sandoz has not received any reports of adverse events or injuries related to the product mislabeling but has received a complaint of administration of the incorrectly labelled product to a patient.

Updates to the prescribing information for two mRNA COVID-19 vaccines, Comirnaty (COVID-19 Vaccine, mRNA), manufactured by Pfizer, and Spikevax (COVID-19 Vaccine, mRNA) manufactured Moderna, to include new safety information about the risks of myocarditis and pericarditis following administration. Information about myocarditis and pericarditis following vaccination with these mRNA COVID-19 vaccines has been included in the labeling since 2021.

A class I recall of Beacon Tip angiographic catheters by Cook after the company became aware that catheters supplied in the affected device lots may experience tip separation. If an affected product is used, potential patient harms such as catheter fragmentation and embolization may occur. Medical consequences associated with device fragmentation or separation may include sepsis, vessel perforation, thrombosis, embolism, cardiac arrythmia, and death. Cook has reported three serious injuries associated with this issue.

A class I recall of Ballard closed suction systems by Avanos Medical, Inc. due to a failure in the sterilization process.

A recall by Baxter of the Novum IQ large-volume pump due to potential for underinfusion following use of the “standby mode” feature, or if the device is powered off with the set loaded. The risk increases when infusing at higher flow rates after longer duration in standby mode or powered off. One serious injury has been associated with this issue.

A recall of the Shiley adult flexible tracheostomy tube with TaperGuard cuff reusable inner cannula by Medtronic and its subsidiary Covidien because the tube may become dislodged or move out of place if the securement flange becomes disconnected.

A recall of all lots within expiry of Zicam cold remedy nasal swabs, Zicam nasal AllClear swabs, and Orajel baby teething swabs to the consumer level by Church & Dwight Co., Inc., due to potential microbial contamination identified as fungi in cotton swab components. Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries. To date, no serious adverse events associated with the affected product have been reported.

A recall of certain Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps by Zyno Medical after they were released with incorrect software versions that had not undergone required verification and validation testing.

A recall of Hippo 072 aspiration systems by Q’Apel Medical, Inc., based on concerns by the FDA about the features and characteristics of the distal tip of the aspiration catheter when removing a clot during aspiration. Two injuries related to this issue have been reported.

A warning added to the antinausea patch Transderm Scop (scopolamine transdermal system) that it can increase body temperature and cause heat-related complications, resulting in hospitalization or sometimes death. Most cases occurred in children ages 17 years and younger and in adults ages 60 years and older, who may be sensitive to body temperature control disturbances. Clinicians should discuss the risk of hyperthermia and associated serious harms when prescribing the patch, especially in children and older adults.

A recall by GE HealthCare of certain Carestation devices due to the risk that they may not provide effective ventilation when used in volume control ventilation mode. The use of affected product may cause serious adverse health consequences, including failure of ventilation resulting in hypoxia and death. GE HealthCare has reported no serious injuries or deaths related to this issue.

A recall of Medline procedure kits containing Medtronic aortic root cannula due to potential excess material in male luers. The use of the affected products may cause procedure delay, neurological deficits, stroke, or death.

A class I recall of the AutoPulse NXT resuscitation system by ZOLL Circulation, Inc., due to a failure code that indicates an error in the correct determination of compression depth. As a result, compressions may stop or may not be deep enough.

A recall of one lot (FA24K05015) of the Ivenix LVP blood products administration set by Fresenius Kabi because it was incorrectly assembled. Use of the affected sets may result in the administration of unfiltered blood or delays in therapy, which—depending on the patient's condition—could cause interruption and underdosing of therapy, unfiltered blood complications, hypotension and other complications, and decreased effectiveness of therapy. Fresenius Kabi has not reported any serious injuries or deaths associated with this issue.

An early alert from Baxter that certain spectrum infusion pumps may have an incorrect version of software. Software intended for spectrum V8 may have been installed on the affected spectrum V6 pumps and vice versa.

A safety communication about potential cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed MN-120 patient monitors that may put patients at risk after being connected to the internet. These cybersecurity vulnerabilities can allow unauthorized actors to bypass cybersecurity controls, gaining access to and potentially manipulating the devices. The FDA is not aware of any incidents related to these cybersecurity vulnerabilities at this time.

A class I recall updating use instructions for CADD-Solis ambulatory infusion pumps and CADD-Solis VIP ambulatory infusion pumps from Smiths Medical. Smiths issued three letters to affected customers about issues relating to false occlusion alarm, thermal damage, and intermittent connection. Potential health consequences include interruptions or delays of therapy, which can lead to serious patient injury or death, depending on the clinical situation and the type of medication being administered. Smiths Medical has not reported any serious injuries or deaths associated with these issues.

A recall of three lots of sulfamethoxazole/trimethoprim tablets, USP, 400 mg/80 mg, by Amneal Pharmaceutical LLC, as the tablets may exhibit black spots on the tablet surface due to microbial contamination. Oral products contaminated with Aspergillus may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections. To date, Amneal Pharmaceuticals has received no reports of adverse events, illnesses, or injuries related to this recall.

Miscellaneous

An announcement that FDA is eliminating Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies. The FDA determined that REMS are no longer necessary to ensure that the benefits outweigh the risks of the following drugs: idecabtagene vicleucel (Abecma), lisocabtagene maraleucel (Breyanzi), ciltacabtagene autoleucel (Carvykti), tisagenlecleucel (Kymriah), brexucabtagene autoleucel (Tecartus), and axicabtagene ciloleucel (Yescarta).

A request for Sarepta Therapeutics to suspend distribution of delandistrogene moxeparvovec (Elevidys) to nonambulatory patients following three deaths from acute liver failure potentially related to investigational gene therapy clinical trials for limb girdle muscular dystrophy.

Import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries. Despite extensive and ongoing efforts to address compliance issues, the FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus and has issued import alerts to prevent future shipments of certain devices from entering the United States, including specific models of ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors.

Approvals

A new indication for lenacapavir (Yeztugo), an injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35 kg. It is the first twice-yearly option available for PrEP. More than 99.9% of participants who received lenacapavir in trials remained HIV negative. The medication was approved for treatment of HIV in 2022.