Exact FDA event identifier

Event 68317

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

Open FDA event record

Event summary

Timeline bucket: May 13, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: CooperSurgical, 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

Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005

Z-1782-2014

Recall number: Z-1782-2014
Initiated: May 13, 2014
Classification: Class II
Status: Terminated
Recalling firm: CooperSurgical, Inc.
Quantity: 1180 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

unsealed pouch

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

Sterility of the device may be compromised due to unsealed pouch

Code information

Lot 141525

Distribution pattern

Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.