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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83119

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

Open FDA event record

Event summary

Timeline bucket
June 14, 2019
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
TELEFLEX-MORRISVILLE

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

Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

Z-0009-2020
Recall number
Z-0009-2020
Initiated
June 14, 2019
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX-MORRISVILLE
Quantity
9,312 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Device vented gas below the stated pressure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device vented gas below the stated pressure.

Code information

Catalog # 2691 SKU #: XTF0046 Lot #'s: 180806, 180910, 181029, 181105, 181204, 190225 and 190327

Distribution pattern

US nationwide distribution. AL, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TX, VA, WA and WY