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Philips Respironics CPAP or Bi-Level PAP therapy masks - recalled due to potential risk of serious injury, USA

3 months ago

United States

These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry.

This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing such magnetic clips to inform them of the updated instructions and labeling. All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described below. This represents a new and industry-leading practice.

Contraindication: Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to:
- Pacemakers
- Implantable cardioverter defibrillators (ICD)
- Neurostimulators
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
- Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)
- Aneurysm clips
- Embolic coils
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates, screws, burr hole covers, and bone substitute devices
- Metallic splinters in the eye
- Ocular implants (e.g., glaucoma implants, retinal implants)
- Certain contact lenses with metal
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
- Magnetic denture attachments
- Metallic gastrointestinal clips
- Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
- Implantable ports and pumps (e.g., insulin pumps)
- Hypoglossal nerve stimulators
- Devices labeled as MR (Magnetic Resonance) unsafe
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field

Patients should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets. Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, switch to a non-magnetic mask if available, for continued therapy.

Patients should properly dispose of the mask that has magnets after an alternative is obtained. These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Warning: Magnets with a magnetic field strength of 400 mT are used in the mask. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 15 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.

Impacted masks include: More than 17 million masks containing magnetic clips have been distributed by Philips Respironics to date. As of August 30, 2022, Philips Respironics has received 14 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues.

Patients may contact their Durable Medical Equipment (DME) provider, which supplied the masks affected by this notice. This voluntary medical device corrective action has been reported to the regulatory agencies in the countries where these masks are available.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Royal Philips’ subsidiary Philips Respironics
Brand name: Philips
Product recalled: Certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps
Reason of the recall: potential risk of serious injury

Source: fda.gov

474


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Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the consumer level.... See More All the recalled lots are listed in the table below, with the additional fourteen (14) lots shown in BOLD and RED. The additional lots were distributed October 26, 2021 through April 25, 2022. Product was distributed nationwide to wholesalers, distributors, and other customers between October 26, 2021 and August 10, 2022. There have been no reports of sterility failures to date with any of the sixty-three (63) lots.

Risk Statement: The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. There is a potential of flying glass injuring skin, eye and/or other parts which could result in either temporary or permanent injury. Within the sixty-three (63) total recalled lots (which includes more than 2.7 million vials), Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no complaints of vial breakage or injuries related to the additional fourteen (14) lots.

Exela did not recall the additional fourteen (14) lots previously because they did not appear to be impacted. During the latest inspection of Exela’s retain product from the fourteen (14) lots, one (1) vial showed breakage. There have been no field reports of personal injury to date across all the sixty-three (63) lots since the recall process started. However, out of an abundance of caution, Exela is adding the 14 lots to the on-going recall. The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Figure 2). The affected Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:

- Brand : Exela . Lot : P0001178 . Expire Date: 05/2023.
- Brand : Exela . Lot : P0001298 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001301 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001313 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001314 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001317 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001330 . Expire Date: 09/2023.
- Brand : Exela . Lot : P0001370 . Expire Date: 10/2023.
- Brand : Exela . Lot : P0001371 . Expire Date: 10/2023.
- Brand : Exela . Lot : P0001372 . Expire Date: 10/2023.
- Brand : Exela . Lot : P0001433 . Expire Date: 11/2023.
- Brand : Exela . Lot : P0001434 . Expire Date: 11/2023.
- Brand : Exela . Lot : P0001442 . Expire Date: 11/2023.
- Brand : Exela . Lot : P0001443 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001464 . Expire Date: 09/2023.
- Brand : Exela . Lot : P0001467 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001468 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001469 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001470 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001472 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001486 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001495 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001505 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001506 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001509 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001510 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001511 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001512 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001532 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001560 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001561 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001562 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001564 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001566 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001567 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001568 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001571 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001572 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001573 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001574 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001578 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001579 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001580 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001583 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001586 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001587 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001588 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001593 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001594 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001610 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001618 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001619 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001644 . Expire Date: 03/2024.
- Brand : Exela . Lot : P0001645 . Expire Date: 03/2024.
- Brand : Exela . Lot : P0001646 . Expire Date: 03/2024.
- Brand : Exela . Lot : P0001654 . Expire Date: 02/2024.
- Brand : Civica . Lot : P0001490 . Expire Date: 12/2023.
- Brand : Civica . Lot : P0001497 . Expire Date: 12/2023.
- Brand : Civica . Lot : P0001600 . Expire Date: 02/2024.
- Brand : Civica . Lot : P0001663 . Expire Date: 03/2024.

The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.

The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.

All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.

Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return).

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Exela Pharma Sciences, LLC
Brand name: Exela
Product recalled: Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial
Reason of the recall: Vial Breakage
FDA Recall date: November 29, 2022

Source: fda.gov
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