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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71966

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

Open FDA event record

Event summary

Timeline bucket
July 29, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Halyard Health, 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

32 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 32

KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2492-2015
Recall number
Z-2492-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
19,250 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2155 - M5166T402, M5166T622, M5166T631; Product Code 2205 - M5079T606, M5086T603, M5089T612, M5089T632, M5110T611, M5110T626, M5166T642; Product Code 8169 - M5103T608; Product Code 8248 - M5082T632; Product Code 22015 - M5082T603, M5089T609, M5096T607; Product Code 22025 - M5082T627, M5096T603; Product Code 220125 M5082T617, M5096T608; Product Code 220135 - M5054T619, M5079T604, M5082T620, M5089T614, M5096T622

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 2 of 32

KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2493-2015
Recall number
Z-2493-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 8308 - M5082T305

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 3 of 32

KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2494-2015
Recall number
Z-2494-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 220569 - AB5145U14, AB5166U09, AB5180U11

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 4 of 32

KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056); KimVent* Wet Pak* Closed Suction System for Adults, 16 F, T-Piece (Product Code 22556); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22012356) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2495-2015
Recall number
Z-2495-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 22056 - AB5124U18, AB5138U01, AB5145U02, AB5145U05, AB5153U03; Product Code 22556 - AB5124U07, AB5131U04; Product Code 22012356 - AB5145U09

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 5 of 32

KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059); KimVent* Closed Suction System for Adults, 14 F, T-Piece, Directional Tip (Product Code 8155) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway

Z-2496-2015
Recall number
Z-2496-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 22059 - M5076T619, M5082T608, M5085T603; Product Code 8155 - M5082T606

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 6 of 32

KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135); KimVent* Closed Suction System for Adults, 12 F, T-Piece, 12 in Trach (Product Code 21513511) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2497-2015
Recall number
Z-2497-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 215135 - M5096T618; Product Code 21513511 M5096T617

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 7 of 32

KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code 227105) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2498-2015
Recall number
Z-2498-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 227105 - M5098T319

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 8 of 32

KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheostomy (Product Code 2201358); KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece (Produce Code 2201258) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2499-2015
Recall number
Z-2499-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2201358 - M5089T629; Product Code 2201258 - M5082T619, M5089T622

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 9 of 32

NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2500-2015
Recall number
Z-2500-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2V220135 - M5081T602, M5089T607, M5089T628, M5106T601; Product Code 2V2205 - M5079T605, M5089T608

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 10 of 32

NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece  MDI Adapter, 14F (Product Code 2V220158) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2501-2015
Recall number
Z-2501-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2V220158 - M5082T629, M5089T623

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 11 of 32

NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2502-2015
Recall number
Z-2502-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2V22059 - M5082T611

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 12 of 32

KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); KimVent* Closed Suction KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 221); KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 22113) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2503-2015
Recall number
Z-2503-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 216 - M5098T617, Product Code 221 - M5079T607, M5082T637, M5166T631; Product Code 22113 - M5089T610, M5166T622

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 13 of 32

KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2504-2015
Recall number
Z-2504-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2219 - M5082T609

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 14 of 32

KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 22169) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2505-2015
Recall number
Z-2505-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2276 -AB5131U06, AB5138U04, AB5161U12; Product Code 22169 - AB5131U09, AB5145U03

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 15 of 32

KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); KimVent* Closed Suction System for Adults, 12 F, DSE (Product 21603); KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 22103); KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 22714183) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2506-2015
Recall number
Z-2506-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2210 - M5054T630, M5082T625, M5089T611, M5117T627; Product Code 21603 - M5089T618, M5103T610; Product Code 22103 - M5089T617; Product Code 22714183  M5082T318

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 16 of 32

KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System for Adults, 14 F, DSE, Wet Pak (Produce Code 221036) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2507-2015
Recall number
Z-2507-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 8224 - AB5161U07; Product Code 22106 - AB5117U03, AB5124U08, AB5124U20, AB5131U03; Product Code 221036 - AB5138U15, AB5161U05

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 17 of 32

KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108); KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 221038) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2508-2015
Recall number
Z-2508-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 22108 - M5082T626, M5089T625; Product Code 221038 - M5089T606, M5089T631

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 18 of 32

KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2509-2015
Recall number
Z-2509-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 22109 - M5082T607

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 19 of 32

NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2510-2015
Recall number
Z-2510-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2V22109 - M5076T629

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 20 of 32

NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2511-2015
Recall number
Z-2511-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2V2210 - M5082T630, M5096T641

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 21 of 32

KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 227); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 22703); KimVent* Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 22716) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2512-2015
Recall number
Z-2512-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 227 - M5082T308, M5166T305; Product Code 22703 - M5082T309, M5103T315; Product Code 22716 - M5091T312, M5145T304

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 22 of 32

KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2513-2015
Recall number
Z-2513-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2273 - M5076T311, M5082T316, M5103T320

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 23 of 32

KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 22705); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 2270135) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2514-2015
Recall number
Z-2514-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 22705 - M5082T301, M5096T315; Product Code 2270135 - M5076T321, M5082T306

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 24 of 32

KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2515-2015
Recall number
Z-2515-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2271418 - M5076T322

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 25 of 32

KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2516-2015
Recall number
Z-2516-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 24-14-5 - M5138T802

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 26 of 32

KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2517-2015
Recall number
Z-2517-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 2401453-5 - M5105T801, M5105T802

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 27 of 32

KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2518-2015
Recall number
Z-2518-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 240438-5 - M5105T809

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 28 of 32

KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2519-2015
Recall number
Z-2519-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 240165-5 - M5089T807

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 29 of 32

KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Y-Adapter (Product Code 196); KimVent* Closed Suction System for Neonates/Pediatrics, 7 F, Y-Adapter (Product Code 197); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter (Product Code 198); KimVent* Closed Suction System for Neonates/Pediatrics 10 F, Y-Adapter (Product Code 1910); KimVent* Closed Suction System for Neonates/.Pediatrics, 12 F, Y-Adapter (Product Code 1912) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2520-2015
Recall number
Z-2520-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 195 -M5061T407; Product Code 196 - M5076T506, M5096T503, M5110T505; Product Code 197- M5082T507; Product Code 198 - M5082T510, M5089T507, M5103T508, M5117T510; Product Code 1910 - M5082T513; Product Code 1912 - M5082T514, M5145T503

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 30 of 32

KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2521-2015
Recall number
Z-2521-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 201 - M5076T405

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 31 of 32

KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 208); KimVent* Closed Suction System for Pediatrics, 10 F, Elbow (Product Code 210); KimVent* Closed Suction System for Neonates/Pediatrics, 10 F, Elbow (Product Code 2103); KimVent* Closed Suction Systems for Neonates/Pediatrics, 8 F, Elbow (Product Code 8313); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 20083) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2522-2015
Recall number
Z-2522-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 206 - M5076T503, M5082T501, M5091T504; Product Code 208 - M5089T506, M5096T507, M5103T509; Product Code 210 - M5091T509; Product Code 2103 - M5082T401, M5089T401, M5138T402; Product Code 8313 - M5089T508; Product Code 20083 - M5082T403, M5082T404, M5089T402, M5103T401, M5166T402

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

device · product 32 of 32

KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Z-2523-2015
Recall number
Z-2523-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Halyard Health, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

Code information

Product Code 8281  AB5138U08, AB5145U16

Distribution pattern

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada