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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83886

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

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Event summary

Timeline bucket
September 16, 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

13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, and central venous pressure monitoring.

Z-0285-2020
Recall number
Z-0285-2020
Initiated
September 16, 2019
Classification
Class II
Status
Terminated
Quantity
75 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.

Code information

REDR0440

Distribution pattern

Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI.