Recall Z-0554-2023 ยท OEQ Angiography/Angioplasty Kit
Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Angio Pack, Item No.686-199,
| Date | Dec 14, 2022 (initiated Nov 2, 2022) |
| Status | Open, Classified |
| Reason | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. |
| Root cause | Packaging process control |
| Action | Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your cus |
| Quantity | 24 units |
| Distribution | US nationwide distribution, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.