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Open, Classified

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.

FDA Recall Z-2790-2018 · Posted None

Recalling FirmGuangzhou Improve Medical Instruments Co., Ltd.
Recall StatusOpen, Classified
Product CodeFMI
Date Initiated2016-10-19
Product Quantity700,000

Reason for Recall

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

Firm Action

Several e-mails were sent between the manufacturer to the US distributor in 2016

Root Cause

Nonconforming Material/Component

Distribution Pattern

Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123987IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SETInnovative Medical Technologies, Inc. · 2013-08-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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