Exact FDA event identifier

Event 75452

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

Open FDA event record

Event summary

Timeline bucket: October 12, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: C.R. Bard, 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

X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.

Z-0363-2017

Recall number: Z-0363-2017
Initiated: October 12, 2016
Classification: Class II
Status: Terminated
Recalling firm: C.R. Bard, Inc.
Quantity: 192 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.

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

Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.

Code information

Lot BMZCE039, Expiration Date 2018-12-31

Distribution pattern

Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.