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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85808

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

Open FDA event record

Event summary

Timeline bucket
June 15, 2020
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Access Scientific 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

POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure.

Z-2550-2020
Recall number
Z-2550-2020
Initiated
June 15, 2020
Classification
Class III
Status
Terminated
Recalling firm
Access Scientific LLC
Quantity
1710

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance.

Code information

Lot number 269939, 270552, 270874, and 272261.

Distribution pattern

US Nationwide distribution including in the state of NY.