CryoLife BioGlue Surgical Adhesive Recalled for Incorrect Lot Labeling
CryoLife, Inc. is recalling 705 boxes of BioGlue Surgical Adhesive because 9 boxes had incorrect lot numbers on their courtesy labels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a minor labeling error (incorrect lot number on courtesy labels) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
CryoLife, Inc. is recalling 705 single pack boxes of BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J. The recall involves Lot Code 17MJX002. The product was distributed in Japan.
The recall was initiated because the courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of the correct lot 17MJX002. This is a labeling error affecting the identification of the specific lot number on the packaging.
No specific instructions for consumers are provided in the source text, but the recall is limited to the specific lot and model number identified above.
The recalled product
- Product
- BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
- Manufacturer
- CryoLife, Inc.
- Hazard
- Affected units
- 705
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)
- Lot Code 17MJX002
- Model/Catalog Number BG3510-5-J
Distribution
Distribution scope not specified by the agency.
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