Recall Z-2277-2019
Suntech Medical, Inc. · initiated June 3, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Codes / lots: Catalog # 98-0400-98 Lot Number: A4H201
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.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-2277-2019
- Initiated
- June 3, 2019
- Terminated
- December 16, 2020
- Product code
- DXQ – Blood Pressure Cuff
- Quantity
- 80 total cuffs affected; 4 Boxes of 20 cuffs
- Distribution
- Pakistan
- Recalling firm
- Suntech Medical, Inc., Morrisville, NC