Mallinckrodt Recalls Unsealed Handi-Fil Disposable Syringe Fill Tubes
Mallinckrodt Inc is recalling 75 cases of Handi-Fil Disposable Syringe Fill Tubes because ten packages were reported as not sealed.
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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The specific hazard is unsealed packaging, which is a quality control issue rather than a direct contamination or structural defect causing injury.
Plain-English summary
Mallinckrodt Inc is recalling 75 cases (100 units per case) of Handi-Fil Disposable Syringe Fill Tubes, Lot #7159027, Catalog #302050. The product is a sterile plastic tube used to transfer radiographic contrast media from a sterile vial to an injection syringe.
The recall was initiated after a Japanese distributor reported a complaint from a hospital customer stating that ten packages of the product were not sealed. The unsealed packaging compromises the sterile integrity of the device.
The affected product was distributed worldwide, including nationwide in the United States and in Australia, Belgium, Brazil, Canada, Japan, and Singapore. Healthcare facilities and distributors should stop using the affected units and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a…
- Manufacturer
- Mallinckrodt Inc
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 (1)
- Lot #7159027 / Catalog #302050
Distribution
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