Exact FDA event identifier

Event 82692

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

Event summary

Timeline bucket: April 09, 2019
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

4 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 4

Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282

Z-1722-2019

Recall number: Z-1722-2019
Initiated: April 09, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 83 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Affected products may have been manufactured with the catheter distal end hole too small

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

Affected products may have been manufactured with the catheter distal end hole too small

Code information

Lot Numbers 7716007 7703324 NS7703501 NS7703502 NS7703503 NS7704718 NS7704722 NS7704727 NS7704728

Distribution pattern

Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA

device · product 2 of 4

Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

Z-1723-2019

Recall number: Z-1723-2019
Initiated: April 09, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 2 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Affected products may have been manufactured with the catheter distal end hole too small

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

Affected products may have been manufactured with the catheter distal end hole too small

Code information

Lot Number NS7726043

Distribution pattern

Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA

device · product 3 of 4

Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030

Z-1724-2019

Recall number: Z-1724-2019
Initiated: April 09, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 2 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Affected products may have been manufactured with the catheter distal end hole too small

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

Affected products may have been manufactured with the catheter distal end hole too small

Code information

Lot Number NS7639280

Distribution pattern

Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA

device · product 4 of 4

Thoracentesis Set, RPN C-THS-850, Order # G03286

Z-1725-2019

Recall number: Z-1725-2019
Initiated: April 09, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Affected products may have been manufactured with the catheter distal end hole too small

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

Affected products may have been manufactured with the catheter distal end hole too small

Code information

Lot Number NS7662071

Distribution pattern

Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA