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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82317

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

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Event summary

Timeline bucket
March 07, 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

BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

Z-1122-2019
Recall number
Z-1122-2019
Initiated
March 07, 2019
Classification
Class II
Status
Terminated
Quantity
6,509,600

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.

Code information

Lot Numbers, UDI: 18041501, (17)210315(10)18041501, (01)50885403235915. 18042501, (17)210325(10)18042501, (01)50885403235915. 18050501, (17)210405(10)18050501, (01)50885403235915. 18051501, (17)210415(10)18051501, (01)50885403235915. 18052501, (17)210425(10)18052501, (01)50885403235915. 18060501, (17)210505(10)18060501, (01)50885403235915. 18061501, (17)210515(10)18061501, (01)50885403235915. 18062501, (17)210525(10)18062501, (01)50885403235915. 18070501, (17)210605(10)18070501, (01)50885403235915. 18072501, (17)210625(10)18072501, (01)50885403235915. 18080501, (17)210705(10)18080501, (01)50885403235915. 18081501, (17)210715(10)18081501, (01)50885403235915.

Distribution pattern

US distribution to the states of FL and NJ.