FDA Device recall Z-2556-2018
BioGlue Spreader Tip, 12mm, Sterile, RX Only
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of BioGlue Spreader Tip, 12mm, Sterile, RX Only by Cryolife, citing 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 pouch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2556-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-04 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cryolife |
| Distribution | n/a |
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).
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.
Identifiers
| code_info | Model Number BG3510-5-J, Lot Number 18MJX002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Cryolife
- BioGlue Surgical Adhesive, Model BG3510-5-G
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2556-2018%22
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