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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80519

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

Open FDA event record

Event summary

Timeline bucket
October 19, 2016
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Guangzhou Improve Medical Instruments 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

Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.

Z-2790-2018
Recall number
Z-2790-2018
Initiated
October 19, 2016
Classification
Class II
Status
Ongoing
Quantity
700,000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.

Code information

Serial Number 102030132 Lots #'s: 20150210 and 20150410

Distribution pattern

Puerto Rico