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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94851

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

Open FDA event record

Event summary

Timeline bucket
June 18, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Embecta Corp.

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 Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/Catalog Number: 320551

Z-2424-2024
Recall number
Z-2424-2024
Initiated
June 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Embecta Corp.
Quantity
185900

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.

Code information

GTIN: (01)10382903205513 Lot Number: 9044773 Expiry Date: 2024/02/29 *The Patient Counseling Sample Toolbox contains BD Nano" 2nd Gen Pen Needles and patient brochures, it has a marketing reference number of 6484755 and lot 3750144.

Distribution pattern

US Nationwide distribution.