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HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, h...

FDA Recall #Z-1113-2020 — Class I — December 13, 2019

Recall #Z-1113-2020 Date: December 13, 2019 Classification: Class I Status: Terminated

Product Description

HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit

Reason for Recall

There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

Recalling Firm

TELEFLEX MEDICAL INC — Morrisville, NC

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

60467 devices

Distribution

nationwide

Code Information

GTIN 14026704659378 Lot Numbers: 74J1500186 74L1502160 74M1500351 74A1600591 74A1601240 74A1602237 74C1601017 74C1602179 74D1600258 74D1601234 74D1601806 74E1600055 74G1600015 74H1600056 74J1601477 74J1602933 74K1602258 74L1600988 74M1600529 74B1701595 74C1700695 74E1702180 74F1700032 74G1700703 74G1700591 74G1700804 74H1701221 74J1700696 74J1700697 74J1700698 74K1700304 74K1702510 74A1802332 74A1802413 74B1801277 74C1800029 74C1800491 74C1800455 74C1801364 74C1801891 74D1800076 74E1800783 74E1800782 74F1800029 74G1800017 74H1801292 74J1800059 74K1800024 74L1800063 74L1802366 74M1800652 74A1901353 74A1901830 74B1900649 74C1900439 74D1900088 74D1900181

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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