CryoLife Recalls BioGlue Spreader Tips Due to Labeling Error
CryoLife, Inc. is recalling BioGlue Spreader Tips because incorrect labels were applied to the packaging, and some required components were missing from the boxes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling and packaging error without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving minor labeling errors or voluntary precautionary recalls.
Plain-English summary
CryoLife, Inc. is recalling 855 units of BioGlue Spreader Tips, 12mm, Sterile, RX Only. The recall involves Model Number BG3510-5-J, Lot Number 18MJX002. The product is indicated for use as an adjunct to standard methods of achieving hemostasis in adult patients undergoing open surgical repair of large vessels.
The recall was initiated because the CryoLife L6318 label was incorrectly applied to the Syringe Applicator Tip pouches. Additionally, the Syringe Spreader Tip pouches were not included in the boxes. The distribution for this recall is to Japan.
Consumers and healthcare providers should stop using the affected BioGlue Spreader Tips and contact CryoLife, Inc. for further instructions or a replacement.
The recalled product
- 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 a
- Manufacturer
- CryoLife, Inc.
- Affected units
- 855
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Number BG3510-5-J
- Lot Number 18MJX002
Distribution
Distribution scope not specified by the agency.
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