Sentara TPN Products Recalled Due to Lack of Sterility Assurance
Sentara Infusion Services is recalling 26 bags of Total Parenteral Nutrition (TPN) solutions distributed nationwide because the manufacturer cannot assure the products maintain sterility. Patients receiving these products should contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or confirmed contamination. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion. Parenteral nutrition products lacking sterility assurance present a theoretical but serious risk of bloodstream infection.
Plain-English summary
Sentara Infusion Services is recalling 26 bags of Total Parenteral Nutrition (TPN) solutions in multiple formulations dispensed to patients nationwide.
The recall was issued because the manufacturer cannot assure sterility of the products. Total Parenteral Nutrition is administered intravenously directly into the bloodstream; products that lack sterility assurance pose a risk of serious bacterial infection.
The recalled products have a beyond-use date of December 2022 and were distributed to patients nationwide for use with or without a Curlin pump. Patients who received these TPN solutions should immediately contact their healthcare provider or Sentara Infusion Services to confirm whether their products are affected and determine the appropriate course of action.
If you have questions about whether a specific TPN product is part of this recall, contact Sentara Infusion Services or consult your healthcare provider. Do not use recalled TPN products.
The recalled product
- Product
- TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML, (d)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (e) 55GM DEX:285GM 1800ML, Rx Only, use with Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeak
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Parenteral Nutrition
- Hazard
- lack-of-sterility
- infection-risk
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)
- Beyond Use Date: December 24-3
- 2022
Distribution
Distributed nationwide across the United States.
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