Menopur 75 IU recall — FDA D-0299-2021
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Complete FDA and NHTSA recall records dated in 2021, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Hyundai Motor America (Hyundai) is recalling certain 2021 Santa Fe vehicles. The Occupant Detection System (ODS) module may not deactivate the air bag upon detection of a child restraint…
Nissan North America, Inc. (Nissan) is recalling certain 2021 Nissan Rogue vehicles. The incorrect wheel nuts may have been installed, and may loosen causing wheel vibration.
Kia Motors America (Kia) is recalling certain 2021 Telluride, K5, and Forte vehicles. The Occupant Classification and Detection System (OCS/ODS) unit may not detect the presence of a child…
Chrysler (FCA US, LLC) is recalling certain 2021 Ram 2500, 3500, and 3500, 4500, and 5500 Cab Chassis vehicles equipped with a Cummins 6.7L Turbo Diesel engine. An electrical short may…
Nissan North America, Inc. (Nissan) is recalling certain 2019-2020 Altima and 2018-2021 Titan vehicles equipped with Continental tires. On the affected vehicles, it is possible that one or…
Honda (American Honda Motor Co.) is recalling certain 2019-2020 Passport and Pilot vehicles equipped with Continental tires. On the affected vehicles, it is possible that one or more tires…
Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had…
The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy…
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing…
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
There is a risk that the device can start a fire if flammable liquids contact and enter the device.
Non-sterile product was shipped to customers labelled as sterile.
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.