Exact FDA event identifier

Event 79199

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

Open FDA event record

Event summary

Timeline bucket: October 03, 2017
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Degania Silicone, Ltd.

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

Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.

Z-0899-2018

Recall number: Z-0899-2018
Initiated: October 03, 2017
Classification: Class III
Status: Terminated
Recalling firm: Degania Silicone, Ltd.
Quantity: 4,000 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

missing labels

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.

Code information

Lot No P1607442.

Distribution pattern

US Distribution to Puerto Rico.