Mallinckrodt Recalls ArterX Surgical Sealant Due to Improper Labeling
Mallinckrodt is recalling ArterX Surgical Sealant because improper labeling led to improper storage. The affected units were distributed to the UK.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is limited to improper storage resulting from labeling errors, which fits the criteria for a moderate severity score.
Plain-English summary
Mallinckrodt Manufacturing LLC is recalling 246 units of Tenaxis Medical ArterX(TM) Surgical Sealant, including 4mL (REF 9002) and 5mL (REF 9006) sterile units. The recall is due to improper labeling that led to improper storage of the product.
The affected lots include 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001, and 40611001. The product was distributed worldwide to the United Kingdom.
Healthcare providers and facilities should stop using the affected ArterX Surgical Sealant units and contact Mallinckrodt for further instructions on return or disposal.
The recalled product
- Product
- Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.
- Manufacturer
- Mallinckrodt Manufacturing LLC
- Affected units
- 246
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 (10)
- Lot Numbers: (a) 211300001
- 20928001
- 30308001
- 30329001
- 3092001
- 31113001
- 40108002
- 40129001
- 40226001
- 40430001 (b) 40611001
Distribution
Distribution scope not specified by the agency.
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