Exact FDA event identifier

Event 88209

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

Open FDA event record

Event summary

Timeline bucket: May 27, 2021
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Mindray DS USA, Inc. dba Mindray North America

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

3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.

Z-2108-2021

Recall number: Z-2108-2021
Initiated: May 27, 2021
Classification: Class III
Status: Terminated
Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Quantity: 804

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Telepack may not power on when using the 3AA battery cradle.

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

Telepack may not power on when using the 3AA battery cradle.

Code information

Part Number 045-001699-01; Awaiting additional details

Distribution pattern

Distributed US nationwide and Canada.