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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86800

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

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Event summary

Timeline bucket
November 11, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Intersurgical 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

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

Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

Z-0753-2021
Recall number
Z-0753-2021
Initiated
November 11, 2020
Classification
Class II
Status
Terminated
Recalling firm
Intersurgical Inc
Quantity
200 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device was assembled with the incorrect exhalation port which can cause gas leakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device was assembled with the incorrect exhalation port which can cause gas leakage.

Code information

Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283

Distribution pattern

All of the devices were shipped to the same distributor (McKesson).