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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84588

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 13, 2019
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
TELEFLEX MEDICAL INC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit

Z-1112-2020
Recall number
Z-1112-2020
Initiated
December 13, 2019
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
30566 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 14026704659361 Lot Numbers: 74D1501285 74J1500185 74M1500350 74A1601241 74C1601016 74C1601472 74C1602180 74D1600257 74D1601233 74D1601232 74E1600054 74G1600014 74H1603490 74J1602886 74J1602885 74B1701597 74F1700031 74G1700590 74G1702197 74J1700026 74J1701902 74K1700026 74K1700900 74L1700541 74A1800863 74A1802331 74B1801424 74C1800022 74D1801520 74E1800781 74G1800923 74K1800769 74M1800651 74A1902597 74D1900087 74D1901071

Distribution pattern

nationwide

device · product 2 of 4

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

Z-1113-2020
Recall number
Z-1113-2020
Initiated
December 13, 2019
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
60467 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

nationwide

device · product 3 of 4

HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit

Z-1114-2020
Recall number
Z-1114-2020
Initiated
December 13, 2019
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
127293 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 14026704659347 Lot Numbers: 74M1400306 74M1400711 74M1401528 74B1500017 74C1501165 74C1502056 74D1500014 74D1500695 74D1501704 74D1501219 74D1501910 74E1500306 74E1501372 74E1501373 74E1501374 74E1501375 74E1501371 74M1500846 74M1501089 74A1600595 74A1601230 74B1600045 74C1601038 74C1601644 74C1602406 74C1601594 74C1602113 74C1602114 74C1602115 74C1602116 74C1602117 74C1602146 74D1600254 74D1600253 74D1601801 74E1600052 74E1601253 74F1600669 74F1603321 74G1600071 74G1601038 74H1600051 74H1600052 74H1603043 74J1601205 74J1601478 74J1602063 74J1602658 74J1602865 74J1602864 74K1602260 74K1602874 74L1600133 74L1601767 74L1602602 74M1600527 74M1601523 74A1700288 74A1700995 74A1701895 74B1701971 74B1702316 74C1701847 74D1700109 74D1701791 74E1700933 74E1702182 74E1702251 74F1700030 74F1702959 74G1700802 74H1700006 74H1700404 74J1700408 74J1701883 74J1701884 74K1700025 74K1700305 74L1700955 74L1701845 74M1700483 74A1801553 74B1801391 74C1802117 74C1802118 74D1800085 74D1801077 74E1800628 74E1800789 74E1802236 74F1800042 74E1803151 74F1801157 74G1800356 74H1800881 74H1802700 74K1800753 74L1802033 74M1800649 74A1900149 74A1901354 74A1901414 74B1900011 74B1900245 74B1902467 74D1901101 74D1903025

Distribution pattern

nationwide

device · product 4 of 4

HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit

Z-1115-2020
Recall number
Z-1115-2020
Initiated
December 13, 2019
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
95696 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 14026704659354 Lot Numbers: 74M1400307 74M1400712 74M1401529 74B1500058 74C1501166 74C1502785 74D1500015 74D1501870 74D1500696 74D1501220 74D1502153 74E1500307 74E1500858 74E1500862 74E1501080 74E1501081 74M1500348 74M1500349 74L1502756 74A1601231 74A1602020 74A1602926 74C1601469 74C1601958 74C1600012 74C1601957 74C1602147 74D1600255 74D1600256 74D1601787 74E1600053 74E1601254 74F1600670 74F1602336 74F1603322 74G1600072 74H1600054 74H1600053 74J1600489 74J1602064 74J1603174 74J1602868 74J1602870 74K1601772 74K1602259 74L1600134 74L1601768 74L1602603 74M1601671 74A1701896 74B1700016 74C1700027 74E1700001 74E1700934 74E1702183 74E1701545 74F1702944 74G1700799 74G1701641 74H1700405 74J1700025 74J1701885 74J1702647 74K1700429 74K1702509 74L1700956 74L1702261 74M1700484 74A1801554 74C1800450 74D1800086 74D1801078 74E1800788 74F1801158 74G1800976 74J1800380 74K1800754 74K1800571 74M1800650 74B1900012 74B1900643 74B1902468

Distribution pattern

nationwide

Field note

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