Device product
BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).
Z-2556-2018
Product summary
- Firm
- CryoLife, Inc.
- Event
- Event 80276
- Status
- Terminated
- Classification
- Class II
- Quantity
- 855 Total
- Official record key
device-enforcement:Z-2556-2018
Official wording
Reason: The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.
Code information: Model Number BG3510-5-J, Lot Number 18MJX002
Distribution pattern: Distribution is to Japan
Derived failure modes
-
Unknown
The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.