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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61943

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

Open FDA event record

Event summary

Timeline bucket
May 29, 2012
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Carefusion 2200 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

3 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 3

AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

Z-1899-2012
Recall number
Z-1899-2012
Initiated
May 29, 2012
Classification
Class I
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.

Code information

product codes 10127-4H1, 10331N-4S2, 10351-4H2, 10387-4S2, 10555-4S2, 10706-4S2, 10790-4S2, 10814-4S2, 10849-4S2, 1175-4H2, 1208-4H1, 1553-4H1, 1815-409, 1998-4H1, 2119-4S2G, 2120-4S2G, 4319-4H2, 4326-4H2, 4652-5014677-4H2, 4875-4H2, 5665-4H2, 5682-409, 5732-4H1, 5868-4H2, 6002-4H2, 6040-501, 6074-4H1, 6198-4H2, 6274-H12, 6301-H12, 6313-501, 6459-4H2; 6485-4H2, 6588-4H2, 6942-4H2, 7100-4S2, 7147-4S2, 7156-4S2, 7184-4S2, 7206-4S2, 7213-4S2, 7354-4S2, 7395-4S2, 7407-4S2, 7441-4S2, 7483-4S2, 7526-4S2, 7575-4S2, 7582-4S2, 7588-4S2, 9053-4S2, 9054-4S2, 9055-4S2, 9056-4S2, 9058-4S2, RC41-12027, RC41-18039, RC41-18052, RC41-18060, RC51-12074, RC51-18004, RT4851-00, RT4851-12 and RT4851-18; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.

device · product 2 of 3

AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

Z-1900-2012
Recall number
Z-1900-2012
Initiated
May 29, 2012
Classification
Class I
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.

Code information

product codes 0260-503; 0778-503, 10392-503, 10416-503, 10448-507, 10734-503, 10852-503, 1209-503, 1535-503, 1853-503, 5599-503, 5643-503, 5898-503, 6189-503, 6800-503 and RC41-00097; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.

device · product 3 of 3

AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

Z-1901-2012
Recall number
Z-1901-2012
Initiated
May 29, 2012
Classification
Class I
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.

Code information

product codes 5925-504 and 6603-504; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.