8046255 Canada Inc. DBA Viatrexx Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial recall — FDA D-0343-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Complete FDA and NHTSA recall records dated in 2019, 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.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Chrysler (FCA US LLC) is recalling certain 2019 Ram 1500 trucks. These vehicles may have been built with a contaminated electric power steering (EPS) gear that may short circuit,…
General Motors LLC (GM) is recalling certain 2019-2020 Chevrolet Silverado 1500 and GMC Sierra 1500, and 2020 Silverado 2500, Silverado 3500, Sierra 2500, and Sierra 3500 vehicles equipped…
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to…
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero connector, following disconnection.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather…
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
Component was not tested by the supplier for adventitious agents
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
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.