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Please note: using the search filters may not provide accurate search results for records prior to November 2021. When searching for older records, please ensure that you use the include archive checkbox.

Displaying 1 - 7 of 7 items.

Health alert or recall LiquiBandFIX8® Open Hernia Mesh Fixation Device
During verification testing, a non-conformance was detected. Failure mode was uncontrolled leakage of glue from the distal tip of the Fix8 Open (FX002) device. Recall start date: Feb 3, 2022
RecallHealth product recall | 2022-02-11
Health alert or recall Dall-Miles products
In October 2021 - Stryker has discovered that there is a potential for the outer Tyvek lid to De-bond from the sealed package. Recall start date: 2021-12-21
RecallHealth product recall | 2022-01-01
Health alert or recall Bellavista Ventilator
Ventilation stops during clinical use, with waveforms and parameters frozen (not updated). a continuous audible/visual high priority alarm for technical failure 305 is generated. ventilation is suspended until unit is rebooted/replaced. Recall start…
RecallHealth product recall | 2021-12-31
Health alert or recall Global Unite Stem
The subject product is being removed because Deputy (Ireland) has determined that select lots of global unite stems may have an undersized spigot bore diameter. Recall start date: Dec 13, 2021
RecallHealth product recall | 2021-12-23
Health alert or recall Quantum Blue Adalimumab Assay
Premature instability of Quantum Blue® Adalimumab Lot Series 3410 leading to an overestimation of Adalimumab trough levels with an approximate bias of +50%. Recall start date: Nov 25, 2021
RecallHealth product recall | 2021-12-08
Health alert or recall Instavac C
Increase in premature device failures occurring in the product manufactured during a specific time period. Recall start date: Nov 16, 2021
RecallHealth product recall | 2021-12-07
Health alert or recall NEURO ZTI
The Neurelec quality system has recently identified an increase in the number of neuro ZTI device explants and devices under surveillance to be explanted because of a loss of hermeticity. The rising trend of early failures compared to…
RecallHealth product recall | 2021-11-12
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