CryoLife recalls BioGlue Spreader Tips due to missing Syringe Spreader Tip pouches in packaging. Affected units have model BG3510-5-J and lot 18MJX002. Consumers should check packaging for indicator label.
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.
CryoLife is recalling BioGlue Spreader Tips that may not include Syringe Spreader Tip pouches. This could lead to incomplete medical procedures during surgery. The recall affects specific model and lot numbers.
The Spreader Tip pouches were not included in the boxes, meaning the necessary components for surgical use might be missing. This could cause incomplete application of BioGlue during procedures. However, the hazard does not involve immediate injury risks.
Adult patients undergoing surgery who use BioGlue for vessel repair may be affected. Medical professionals handling the specific model and lot numbers are most at risk.
Check for model number BG351:5-J and lot number 18MJX002 on the packaging. The indicator label should read '2 1/8" x 1 1/4"'.
Look for the model number BG3510-5-J and lot number 18MJX002 on the packaging.
The Spreader Tip pouches were not included in the boxes, which could lead to missing components during surgical procedures.
Check the packaging for model number BG3510-5-J and lot number 18MJX002. If it matches, contact CryoLife for further instructions.
The recall is for missing components, not an immediate injury risk. The hazard does not involve serious injury in normal use.
We’ve drafted a message you can send CryoLife to request your refund or repair — edit it as you like.
Subject: Recall Z-2556-2018 — CryoLife CryoLife Hello, I own a CryoLife that is covered by recall Z-2556-2018 from CryoLife. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
