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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84859

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

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Event summary

Timeline bucket
August 19, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
RESPIRATORY THERAPEUTICS GROUP LLC

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

RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway.

Z-1443-2020
Recall number
Z-1443-2020
Initiated
August 19, 2019
Classification
Class II
Status
Ongoing
Quantity
723 cases (7230 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

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Inspect official wording and provenance

Reason for recall

It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.

Code information

Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019

Distribution pattern

US Nationwide distribution in the states of CA, NJ, NY. OUS: None