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Terminated

SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20

FDA Recall Z-2277-2019 · Posted None

Recalling FirmSuntech Medical, Inc.
Recall StatusTerminated
Product CodeDXQ
Date Initiated2019-06-03
Date Terminated2020-12-16
Product Quantity80 total cuffs affected; 4 Boxes of 20 cuffs

Reason for Recall

Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.

Firm Action

On June 3, 2019, SunTech Medical sent an Urgent Medical Device Customer Notification to their one consignees advising them of the issue and requesting that they completed the enclosed Recall Acknowledgement Form. This letter further request this consignee to conduct a sub-recall by using the provided Customer Template Letter and Recall Acknowledgement Template.

Root Cause

Labeling Change Control

Distribution Pattern

Pakistan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080854DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100Suntech Medical, Inc. · 2008-10-20

Official Source

View FDA Recall →

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

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