Western / Scott Fetzer Company Grab n Go Opti series VIPR system Model # PRX-9615 - Product recall — FDA Z-0339-2020
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
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.
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
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.
There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
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.
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.
Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which…
There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches…
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
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).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus…
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
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).
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.