Exact FDA event identifier

Event 88057

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

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Event summary

Timeline bucket: May 19, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Bard Access Systems 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

5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire

Z-1994-2021

Recall number: Z-1994-2021
Initiated: May 19, 2021
Classification: Class II
Status: Terminated
Recalling firm: Bard Access Systems Inc.
Quantity: 30 kits

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

labeled with 70cm guidewires, but contained

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.

Code information

Catalog (REF) Number: CK000340B UDI Code: (01)00801741126697 Lot Number: 20BBK658

Distribution pattern

U.S. Nationwide distribution in the state of RI.