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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87504

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

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Event summary

Timeline bucket
March 02, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo Cardiovascular Systems Corporation

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

Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.

Z-1367-2021
Recall number
Z-1367-2021
Initiated
March 02, 2021
Classification
Class II
Status
Terminated
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

Code information

GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.

Distribution pattern

US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.

Field note

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