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Open, Classified

Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO

FDA Recall Z-2549-2018 · Posted None

Recalling FirmGuangzhou Improve Medical Instruments Co., Ltd.
Recall StatusOpen, Classified
Product CodeFMI
Date Initiated2017-09-22
Product Quantity200,000

Reason for Recall

Leaks complaints.

Firm Action

Several e-mails in early 2017 were sent to their only US consignee.

Root Cause

Under Investigation by firm

Distribution Pattern

Kansas

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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