Recall Z-0996-2023 ยท GBX Catheter, Irrigation
Maquet Cardiovascular, LLC
Vasoshield Syringe Packs, Model VH-5001
| Date | Jan 19, 2023 (initiated Dec 22, 2022) |
| Status | Open, Classified |
| Reason | Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event. |
| Root cause | Under Investigation by firm |
| Action | URGENT MEDICAL DEVICE Removal notification letters dated 12/22/22 were sent to customers. Actions to be taken by the Customer: Our records indicate that you have received the Hemopro 2 with Vasoshield and Vasoshield Syringe from lots affected by this recall. Please, note that Distributed Affected Lot Numbers appear on the device shelf boxes only. Please examine your inventory immediately to determine if you have any of Hemopro 2 with Vasoshield and/or Vasoshield Syringe with the product code/lot numbers listed in this notice. LOT numbers can be found on the product label in the area circle |
| Quantity | 530 units US, 215 units OUS |
| Distribution | US Nationwide. Japan, Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082725 | GRAFTGUARD PRESSURE CONTROLLING SYRINGE Maquet Cardiovascular, LLC, Dec 17, 2008 |