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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87158

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

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Event summary

Timeline bucket
December 23, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Becton Dickinson & Company

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

BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482

Z-1109-2021
Recall number
Z-1109-2021
Initiated
December 23, 2020
Classification
Class II
Status
Terminated
Quantity
155,200 needles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open seal
Sterility assurance reason.sterility_assurance · v1.0.0
packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility

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

The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.

Code information

Catalog (Ref No.) 305482 100/package UDI 00382903054824 Lot # 8142303 exp date 31-May-2023

Distribution pattern

Distribution US nationwide and Canada

Field note

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