Exact FDA event identifier

Event 76587

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

Open FDA event record

Event summary

Timeline bucket: February 27, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: CORENTEC CO., LTD

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

Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343

Z-1454-2017

Recall number: Z-1454-2017
Initiated: February 27, 2017
Classification: Class II
Status: Terminated
Recalling firm: CORENTEC CO., LTD
Quantity: 5 ea

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.

Code information

Lot Number: 10AFFQ21 Expiration Date: 2021-11-28

Distribution pattern

US Distribution to the state of : PA