Z-2556-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- June 4, 2018
- Termination Date
- February 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 855 Total
Product Description
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).
Reason for Recall
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.
Distribution Pattern
Distribution is to Japan
Code Information
Model Number BG3510-5-J, Lot Number 18MJX002