Exact FDA event identifier

Event 88048

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

Open FDA event record

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

5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer

Z-1991-2021

Recall number: Z-1991-2021
Initiated: May 19, 2021
Classification: Class II
Status: Terminated
Recalling firm: Bard Access Systems Inc.
Quantity: 180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Catheter kits contained the incorrect micro-introducers.

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 kits contained the incorrect micro-introducers.

Code information

Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201

Distribution pattern

U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None