SCA Pharmaceuticals morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection recall — FDA D-0202-2021
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two…
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Volvo Cars USA, LLC (Volvo Car) is recalling certain 2021 Volvo V60, V60 Cross Country, V90, V90 Cross Country, XC60, and XC90 vehicles. The Supplementary Restraint System (SRS) control…
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the…
Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the…
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the…
The expiration date on labeling is incorrect.
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the…
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential…
Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the…
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential…
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential…
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential…
During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results…
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the…
May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or…
The device was assembled with the incorrect exhalation port which can cause gas leakage.
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative…
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