Recall Z-1172-2018
Getinge US Sales LLC · initiated January 3, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Codes / lots: UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229
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).
FDA-determined cause: Labeling mix-ups
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
Details
- Recall number
- Z-1172-2018
- Initiated
- January 3, 2018
- Posted by FDA
- March 20, 2018
- Terminated
- July 3, 2018
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Quantity
- 1
- Distribution
- FL
- Recalling firm
- Getinge US Sales LLC, Wayne, NJ