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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86619

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

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Event summary

Timeline bucket
October 05, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bayer Medical Care, 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.

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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

Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.

Z-0483-2021
Recall number
Z-0483-2021
Initiated
October 05, 2020
Classification
Class II
Status
Terminated
Recalling firm
Bayer Medical Care, Inc.
Quantity
92,420 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.

Code information

Catalog/REF Number: FLEXD-150-SCS Material Number: 87078817 Lot Numbers: 8584324, 8586383, 8586384, 8586385, 8586386, 8586388 UDI Numbers: (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 Catalog/REF Number: FLEXD-150-SPK Material Number: 85020218 Lot Number: 8585234 UDI Numbers: (01)00616258010656(11)200720(17)240720(10)8585234

Distribution pattern

Distributed to healthcare facilities nationwide throughout the US.