HEMASHIELD Knitted Double Velour Cardiovascular Fabric
FDA device recall Z-1172-2018 · posted 2018-03-20 · Terminated
Recall details
- Recalling firm
- GETINGE US SALES LLC
- Reason for recall
- 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).
- Action taken
- 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
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DXZ
- Quantity affected
- 1
- Distribution
- FL
- Date initiated
- 2018-01-03
- Date posted
- 2018-03-20
- Date terminated
- 2018-07-03
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC (K955349) | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-14 |