Z-2790-2018Class II

Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO

Name: Z-2790-2018 Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO
Creator: Guangzhou Improve Medical Instruments Co., Ltd.
Published: 2016-10-19
License: https://open.fda.gov/license/

Guangzhou Improve Medical Instruments Co., Ltd. / initiated 2016-10-19 / Open, Classified / root cause: manufacturing process

FDA source

Guangzhou Improve Medical Instruments Co., Ltd. began a recall of Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle... on 2016-10-19. FDA classified it as Class II and gives the reason as "Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2790-2018
Classification: Class II
Status: Open, Classified
Initiated: 2016-10-19
Posted: 2018-08-12
Recalling firm: Guangzhou Improve Medical Instruments Co., Ltd.
Product: 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.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Several e-mails were sent between the manufacturer to the US distributor in 2016
Quantity in commerce: 700,000
Distribution: Puerto Rico
Product codes and lots: Serial Number 102030132 Lots #'s: 20150210 and 20150410

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2790-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2790-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-22	2018-08-11

Product code FMI

K123987Class IIImprove Blood Collection Set and Improsafe Blood Collection SetInnovative Medical Technologies, Inc. / cleared 2013-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)