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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79910

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

Open FDA event record

Event summary

Timeline bucket
April 13, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Parker Laboratories, 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

Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case

Z-1777-2018
Recall number
Z-1777-2018
Initiated
April 13, 2017
Classification
Class II
Status
Terminated
Recalling firm
Parker Laboratories, Inc.
Quantity
3275 cases/1310000 packets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the gel packets to have leaks in the packet seal.

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

There is a potential for the gel packets to have leaks in the packet seal.

Code information

Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006

Distribution pattern

The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA. The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta.