Pentec Health Recalls Proplete 52 Intradialytic Nutrition Due to Sterility Concerns
Pentec Health is recalling Proplete 52 intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric, particularly given the risk of infection from non-sterile medical products.
Plain-English summary
Pentec Health Inc is recalling Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids) in 485mL and 490mL bags. The recall is due to a lack of assurance of sterility, as sterility could not be assured for the compounded sterile renal nutritional prescriptions.
The affected product was distributed to dialysis centers and directly to patients. The recall includes 25 bags with compounding dates of 04/24/13, 04/25/13, and 04/29/13, and discard dates of 05/15/13, 05/16/13, and 05/20/13.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or Pentec Health for further instructions.
The recalled product
- Product
- Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
- Manufacturer
- Pentec Health
- Affected units
- 25
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 (5)
- Compounding Date: 04/24/13
- 04/25/13
- 04/29/13 Discard after: 05/15/13
- 05/16/13
- 05/20/13
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Pentec Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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