Complete FDA and NHTSA recall records dated in November 2019.
These records include useful source details for the selected month.
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).
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.
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).
One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.
Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS…
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
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).
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
