Liquid adhesive vials recalled because the butyrate tube cracks during actuation
Ferndale Laboratories is recalling 24,589 units of Mastisol Liquid Adhesive because the butyrate tube cracks during actuation, rendering the product unusable.
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: Scored 2 because the record's stated effect is that the product is rendered unusable, with no patient harm or reported injury.
Plain-English summary
Mastisol Liquid Adhesive, catalog number 0523-48, supplied as a 2/3 mL vial with 48 vials per carton, is being recalled by Ferndale Laboratories, Inc.
The reason given in the enforcement record is that the butyrate tube cracks during actuation, rendering the product unusable.
The record lists 24,589 units from lot 24161B, expiry 10-31-2029, carrying DI number 00304960523488. Distribution was worldwide, including nationwide in the United States and to the United Kingdom. The FDA has classified the action as Class II.
The record describes a product that cannot be used and states no further consequence or reported injuries. Facilities should follow Ferndale's instructions.
The recalled product
- Product
- Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No
- Manufacturer
- Ferndale Laboratories, Inc.
- Category
- Medical Device — Liquid adhesive
- Hazard
- cracking
- device-unusable
- packaging
Distribution
Distributed nationwide across the United States.
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