Recall Z-2556-2018 ยท MUQ Glue, Surgical, Arteries
CryoLife, Inc.
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).
| Date | Jun 4, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| Action | CyroLife notified their customers on/about 06/04/2018 via Urgent - Important Product Removal letter. instructions indicated that affected pouches have been returned to CryoLife, Inc. Any questions/clarifications regarding this removal are directed to contact 800-438-8285 or by email to fieldassurance@c ryolife.com. |
| Quantity | 855 Total |
| Distribution | Distribution is to Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.