FDA Medical Device Recalls (openFDA)
Suntech Medical, Inc.: SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
- Recall number
- Z-2277-2019
- Recalling firm
- Suntech Medical, Inc.
- Product
- SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
- Status
- Terminated
- Initiated
- 2019-06-03
- Posted
- not on file
- Terminated
- 2020-12-16
- Reason
- 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.
- Root cause
- Labeling Change Control
- 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.
- Quantity
- 80 total cuffs affected; 4 Boxes of 20 cuffs
- Distribution
- Pakistan
- Lot, serial or model codes
- Catalog # 98-0400-98 Lot Number: A4H201
- 510(k) numbers
- ["K080854"]
- PMA numbers
- not on file
- Product code
- DXQ
- Firm FEI
- 1036863
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28