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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85187

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 06, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cook 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

2 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 2

Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643

Z-1565-2020
Recall number
Z-1565-2020
Initiated
March 06, 2020
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The printed expiration dates are incorrect.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The printed expiration dates are incorrect.

Code information

Lot Number 10119247; UDI: (01)00827002106437(17)921110(10)10119247

Distribution pattern

The products were distributed to the following US states: CO, DE, MD, MN, NC, NV, and WV. The products were distributed to the following foreign countries: Canada.

device · product 2 of 2

Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053

Z-1566-2020
Recall number
Z-1566-2020
Initiated
March 06, 2020
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The printed expiration dates are incorrect.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The printed expiration dates are incorrect.

Code information

Lot Number 10235662; UDI: (01)00827002480537(17)562310(10)10235662

Distribution pattern

The products were distributed to the following US states: CO, DE, MD, MN, NC, NV, and WV. The products were distributed to the following foreign countries: Canada.