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Safe-T Plus Lumbar Puncture Tray (Bard) – Manometer Failure (2022)

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

FDAJan 20, 2022Nationwide• Bard Peripheral Vascular Inc

QMS Tacrolimus Calibrator (Microgenics) – Value Recovery Issue (2022)

Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.

FDAJan 20, 2022AL, AZ, CA +18 more• Microgenics Corporation

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Safe-T Plus Lumbar Puncture Tray (Bard) – Manometer Failure (2022)

QMS Tacrolimus Calibrator (Microgenics) – Value Recovery Issue (2022)

Lumbar Puncture Tray Adult (Bard) – Manometer Failure (2022)

YelloPort Elite Trocar (Surgical Innovations) – Sterility Labeling (2022)

Tablo Console (Outset Medical) – Heat Damage Risk (2022)

Sight OLO Blood Analysis Device (Sight Diagnostics) – Reference Range Issue (2022)

Pediatric Lumbar Puncture Tray (Bard) – Manometer Failure (2022)

2021 Heartland Cyclone (Heartland) – Tire Tread Issue (2022)

2022 Spartan Fire MetroStar (Spartan Fire) – Axle Assembly Problem (2022)

Lumbar Puncture Tray Pediatric (Bard) – Manometer Failure (2022)

FRIGG Silicone Pacifiers (FRIGG) – choking hazard (2022)

ACUSON Juniper Ultrasound (Siemens) – Clip Store Malfunction (2022)

SyncVision Systems (Volcano) – Measurement Calculation Error (2022)

Tri-Ace Pioneer A/T III Tire (Tri-Ace) – Sidewall Defect (2022)

2019 Dennis Eagle Proview (Dennis Eagle) – Window Operation Issue (2022)

Children's Sleepwear Garments (Childrensalon) – flammability violation (2022)

2022 Peterbilt 579 (Peterbilt) – Chassis Fairing Bolt Problem (2022)

LINQ II Cardiac Monitor (Medtronic) – Moisture Ingress Risk (2022)

2022 Keystone Alpine (Keystone) – Ladder Safety Problem (2022)

Opaque Herrick Lacrimal Plugs (Lacrimedics) – Pouch Seal Issue (2022)