Pentec Health Recalls Proplete 34-39 KG Intradialytic Nutrition Bags
Pentec Health is recalling Proplete 34-39 KG intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
The agency’s classification
FDA (Drugs): 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a critical sterility failure in a parenteral nutrition product which carries a high risk of serious infection, align with the 'Severe' criteria (Score 4).
Plain-English summary
Pentec Health Inc. is recalling Proplete 34-39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water) in 330mL 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 specific compounding date for the recalled units is April 25, 2013, with a discard after date of May 16, 2013.
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 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132
- Manufacturer
- Pentec Health
- Category
- Drug — Parenteral Nutrition
- Affected units
- 1
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)
- Compounding Date: 4/25/13 Discard after: 5/16/13
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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