Dunnage Case Shipped Instead of THERAKOS CELLEX Photopheresis Kits
A dunnage case containing sterilization packaging was shipped in place of THERAKOS CELLEX Photopheresis Procedural Kits. The material is not intended for customer use and should not be used.
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: This is an FDA Class II recall with no reported illnesses or injuries. The issue is a shipping error in which sterilization packaging was sent instead of the actual medical device kits—an administrative and fulfillment problem rather than a product safety hazard.
Plain-English summary
Mallinckrodt Pharmaceuticals Ireland Ltd is recalling a dunnage case that was shipped on December 2, 2021, in place of Kit lot K341. Dunnage is protective material used in the sterilization process of medical devices and is not intended for customer or clinical use.
Affected customers received the dunnage case instead of the expected THERAKOS CELLEX Photopheresis Procedural Kits. If you received this shipment in error, do not use the material and contact the manufacturer immediately. The recall affected customers nationwide in California, Florida, Georgia, Massachusetts, Michigan, North Carolina, New Jersey, New York, Ohio, Tennessee, Texas, Virginia, and West Virginia.
The recalled product
- Product
- THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
- Manufacturer
- Mallinckrodt Pharmaceuticals Ireland Ltd
- Hazard
- Affected units
- 3
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 (2)
- Dunnage case consists of a random unknown lot
- which may have been shipped in place of Kit lot K341
Distribution
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