Exact FDA event identifier

Event 83051

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

Open FDA event record

Event summary

Timeline bucket: June 10, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Santanello Surgical LLC

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

VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter

Z-2237-2019

Recall number: Z-2237-2019
Initiated: June 10, 2019
Classification: Class II
Status: Terminated
Recalling firm: Santanello Surgical LLC
Quantity: 98

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

package integrity may compromise

Sterility assurance reason.sterility_assurance · v1.0.0

package integrity may compromise sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of package integrity may compromise sterility

Code information

Lot: SAN1003 UDI: (01)00810805000026(10)SAN0003(17)160205

Distribution pattern

FL,OK, OH, NY, ME, MN, WI