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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73151

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

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Event summary

Timeline bucket
January 28, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Gi Supply

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

Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04

Z-1047-2016
Recall number
Z-1047-2016
Initiated
January 28, 2016
Classification
Class II
Status
Terminated
Recalling firm
Gi Supply
Quantity
390 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.

Code information

Lot #: 61442434 Expiration Date: 2018/04

Distribution pattern

Distributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN.