Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89216

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

Open FDA event record

Event summary

Timeline bucket
December 09, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Greiner Bio-One North America, 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

greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P

Z-0502-2022
Recall number
Z-0502-2022
Initiated
December 09, 2021
Classification
Class II
Status
Terminated
Quantity
889,200 pcs.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some of the blood collection tubes show clotting due to variation of Lithium Heparin.

Code information

Lot #B21053QG, Exp. 09/09/2022, UDI: Case: 39120017579046, Rack: 29120017579049.

Distribution pattern

Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.