Cook Biotech Recalls Biodesign Fistula Plugs Due to Expiration Date Errors
Cook Biotech is recalling 93 Biodesign Fistula Plugs because the products expire prior to the expiration date printed on the labeling.
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 2/5 (Moderate).
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 and involves a labeling error regarding expiration dates. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries are rated as Moderate.
Plain-English summary
Cook Biotech, Inc. is recalling 93 units of Biodesign Fistula Plug C-FPS-0.4. The recall is due to a labeling error where the products expire prior to the expiration date printed on the product labeling.
The affected devices are intended for implantation to reinforce soft tissue for the repair of recto-vaginal or anorectal fistulas. The recall covers specific lot numbers and is distributed worldwide, including the United States, Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, and the United Kingdom.
Consumers and healthcare providers should stop using the affected products and contact Cook Biotech, Inc. for further instructions or a return.
The recalled product
- Product
- Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613
- Manufacturer
- Cook Biotech, Inc.
- Affected units
- 93
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Cook Biotech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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