Exact FDA event identifier

Event 90250

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

Event summary

Timeline bucket: May 02, 2022
Product types: Device
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Getinge Usa Sales 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

2 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 2

Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700

Z-1278-2022

Recall number: Z-1278-2022
Initiated: May 02, 2022
Classification: Class I
Status: Terminated
Recalling firm: Getinge Usa Sales Inc
Quantity: 17 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.

Code information

UDI-DI: 07325710009765 Serial Numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078. (Note: UDI was corrected July 7, 2022)

Distribution pattern

US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia

device · product 2 of 2

Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900

Z-1279-2022

Recall number: Z-1279-2022
Initiated: May 02, 2022
Classification: Class I
Status: Terminated
Recalling firm: Getinge Usa Sales Inc
Quantity: 47 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

UDI-DI: 07325710010457 Serial Numbers: 50012, 50013, 50014, 50015, 50016, 50017, 50030, 50031, 50033, 50034, 50035, 50036, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50046, 50047, 50048, 50051, 50052, 50053, 50054, 50055, 50056, 50057, 50058, 50059, 50060, 50061, 50062, 50069, 50070, 50071, 50072, 50073, 50074, 50084, 50085, 50086, 50087, 50088, 50089, 50090, 50091, 50092, 50093, 50094, 50096, 50097, 50108, 50109, 50110, 50111, 50132. (Note: UDI was corrected July 7, 2022)

Distribution pattern

US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia