Recall Z-1172-2018 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
GETINGE US SALES LLC
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
| Date | Mar 20, 2018 (initiated Jan 3, 2018) |
| Status | Terminated |
| Reason | A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length). |
| Root cause | Labeling mix-ups |
| Action | On January 3, 2018 an URGENT MEDICAL DEVICE RECALL NOTICE was issued to the (1) affected customer. A return authorization was issued with the recall letter, which is intended to be returned to the recalling firm. Questions or concerns can be directed to 1-800-528-7486 |
| Quantity | 1 |
| Distribution | FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955349 | HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC Meadox Medicals, Div. Boston Scientific Corp., Feb 14, 1996 |