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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86146

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

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Event summary

Timeline bucket
July 31, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Klarity Medical Products 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

Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.

Z-2881-2020
Recall number
Z-2881-2020
Initiated
July 31, 2020
Classification
Class II
Status
Terminated
Quantity
111 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.

Code information

Lots R7504-30C: 70621Y and 81008X R7504-35BC: 70415V and 71220V R7504-35C: 81008W R7644-32.5BC: 71228S RC7221-25BC: 70502Y and 70621W RC7504-17.5C: 80411A and 80802W

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.