Exact FDA event identifier

Event 75291

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

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Event summary

Timeline bucket: July 29, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: B. Braun Medical, Inc.

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

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

Z-0691-2017

Recall number: Z-0691-2017
Initiated: July 29, 2016
Classification: Class II
Status: Terminated
Recalling firm: B. Braun Medical, Inc.
Quantity: 15,950 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

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.

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Inspect official wording and provenance

Reason for recall

Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

Code information

Lot Number 361105, exp date 1/01/2017, Product Catalog Number 375198

Distribution pattern

Nationwide Distribution to GA, IL, and FL