Exact FDA event identifier

Event 80197

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

Open FDA event record

Event summary

Timeline bucket: January 12, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medline Industries, 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

BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.

Z-2378-2018

Recall number: Z-2378-2018
Initiated: January 12, 2018
Classification: Class II
Status: Terminated
Recalling firm: Medline Industries, Inc.
Quantity: 6/5-kit cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

One of the cases of product might not have been sterilized.

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

One of the cases of product might not have been sterilized.

Code information

Lot 17YM5936, Exp. 04/30/2019

Distribution pattern

The product was distributed to UT.