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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69910

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

Open FDA event record

Event summary

Timeline bucket
November 17, 2014
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Halyard Health

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

5 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 5

KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

Z-0865-2015
Recall number
Z-0865-2015
Initiated
November 17, 2014
Classification
Class I
Status
Terminated
Recalling firm
Halyard Health
Quantity
250 cases (10 tubes per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The cuff inflation line may detach from the endotracheal tube during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The cuff inflation line may detach from the endotracheal tube during use.

Code information

Product Code: 13220, Lot numbers: AA3213, AA3227, AA3227V01, AA3245, AA3245V02, AA3253V02, AA3269V01, AA3274V01, AA4038, AA4038V03, AA4038V04, AA4038V06, AA4062, AA4062V01, AA4104V02, AA4111V01, AA4113V01, AA4134V01 & AA4146V01, AA4146V04, AA4174V01.

Distribution pattern

Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.

device · product 2 of 5

KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

Z-0866-2015
Recall number
Z-0866-2015
Initiated
November 17, 2014
Classification
Class I
Status
Terminated
Recalling firm
Halyard Health
Quantity
430 cases (10 tubes per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The cuff inflation line may detach from the endotracheal tube during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The cuff inflation line may detach from the endotracheal tube during use.

Code information

Product Code: 13221, Lot numbers: AA3213, AA3213V01, AA3231, AA3231V01, AA3249, AA3249V02, AA3253, AA3253V01, AA3274, AA3274V03, AA4062, AA4062V02, AA4062V06, AA4097, AA4097V01, AA4097V03, AA4125V01, AA4134V02, AA4140, AA4140V01, AA4142, AA4142V01, AA4146V02, AA4167V03, AA4170 & AA4170V02.

Distribution pattern

Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.

device · product 3 of 5

KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

Z-0867-2015
Recall number
Z-0867-2015
Initiated
November 17, 2014
Classification
Class I
Status
Terminated
Recalling firm
Halyard Health
Quantity
400 cases (10 tubes per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The cuff inflation line may detach from the endotracheal tube during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The cuff inflation line may detach from the endotracheal tube during use.

Code information

Product Code: 13222, Lot numbers: AA3213, AA3213V03, AA3227, AA3227V01, AA3239, AA3239V01, AA3245, AA3245V02, AA3249, AA3249V01, AA3249V03, AA3253V02, AA3269V01, AA3274, AA3274V01, AA3274V04, AA4038, AA4038V03, AA4038V04, AA4038V06, AA4062, AA4062V01, AA4062V03, AA4062V04, AA4083, AA4083V02, AA4097, AA4097V02, AA4097V04, AA4104V01, AA4104V02, AA4111, AA4111V01, AA4111V02, AA4113V01, AA4125V03, AA4134V01, AA4146V01, AA4146V04, AA4155V03, AA4167V01, AA4170V01, AA4174V01, AA4217V01 & AA4226V01.

Distribution pattern

Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.

device · product 4 of 5

KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

Z-0868-2015
Recall number
Z-0868-2015
Initiated
November 17, 2014
Classification
Class I
Status
Terminated
Recalling firm
Halyard Health
Quantity
130 cases (10 tubes per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The cuff inflation line may detach from the endotracheal tube during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The cuff inflation line may detach from the endotracheal tube during use.

Code information

Product Code: 13223, Lot numbers: AA3203V03, AA3234, AA3234V01, AA3260, AA3260V01, AA4038, AA4038V01, AA4038V02, AA4038V05, AA4077, AA4077V01, AA4083, AA4083V01, AA4092V01 & AA4125V02.

Distribution pattern

Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.

device · product 5 of 5

KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

Z-0869-2015
Recall number
Z-0869-2015
Initiated
November 17, 2014
Classification
Class I
Status
Terminated
Recalling firm
Halyard Health
Quantity
80 cases (10 tubes per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The cuff inflation line may detach from the endotracheal tube during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The cuff inflation line may detach from the endotracheal tube during use.

Code information

Product Code: 13224, Lot numbers: AA3274, AA3274V02, AA4062, AA4062V05, AA4092V02, AA4104V01, AA4111V03, AA4174V02 & AA4190V01.

Distribution pattern

Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.