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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91579

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 16, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Vapotherm

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

1 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 1

Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW

Z-1272-2023
Recall number
Z-1272-2023
Initiated
December 16, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Vapotherm
Quantity
5869 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.

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

There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.

Code information

UDI-DI: 00841737104971, Lot Numbers: LFVMA8503, LFVMA8504, LFVMA8567; UDI-DI: 00841737104978, Lot Number: LFVLE8568 Additional Lot Numbers: LFTL41015 LFVLC8399 LFVLE8495 LFVMA8502 LFVMA8503 LFVMA8504 LFVMA8567 LFTL41261 LNTL41544 LFVLE8588 LFVMA8507 LFVLE8568 LFVLE8494 LFTL41263 LFTL41262

Distribution pattern

Worldwide distribution - US Nationwide and the country of UK.