Coloplast Recalls Digitex Sutures Due to Incorrect Expiration Date Labeling
Coloplast is recalling three lots of Digitex Absorbable Polydiaxanone Sutures because they are mislabeled with a three-year expiration date.
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 the hazard is a labeling error regarding the expiration date, which fits the criteria for moderate severity involving minor labeling errors.
Plain-English summary
Coloplast Manufacturing US, LLC is conducting a recall of three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0. The affected lots are 3390331, 3390339, and 3390490. The recall involves 772 units of the product.
The reason for the recall is that the product is mislabeled with a three-year expiration date. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site.
The affected products were distributed in Kentucky, Michigan, Ohio, Puerto Rico, Texas, and Virginia. Users should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through…
- Manufacturer
- Coloplast Manufacturing US, LLC
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 772
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 (3)
- Lots 3390331
- 3390339
- 3390490.
Distribution
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