Exact FDA event identifier

Event 83537

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

Open FDA event record

Event summary

Timeline bucket: August 01, 2019
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

8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008

Z-2411-2019

Recall number: Z-2411-2019
Initiated: August 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Becton Dickinson & Company
Quantity: 700 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Pouches may not be sealed properly and compromise the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Pouches may not be sealed properly and compromise the sterility of the device

Code information

Lot Number: 0001159474 Exp. Date: 2022-08-31 UDI: (01)10885403044564 + (10)0001159474(17)220831

Distribution pattern

CA, IL Foreign: Taiwan