Recall Z-2277-2019 ยท DXQ Blood Pressure Cuff
Suntech Medical, Inc.
SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
| Date | Jun 3, 2019 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080854 | DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 Suntech Medical, Inc., Oct 20, 2008 |