Pentec Health Recalls Baxter Ultrabag Amino Acids Due to Sterility Concerns
Pentec Health is recalling Baxter Ultrabag 1.5% Amino Acids because sterility could not be assured for 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 context, a critical sterility failure in a sterile product, align with a Severe rating (Score 4).
Plain-English summary
Pentec Health Inc. is recalling Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids) in 1500mL and 3000mL bags. The recall is due to a lack of assurance of sterility for compounded sterile renal nutritional prescriptions.
The affected units were distributed to dialysis centers and directly to patients. The specific units involved have a date of 04/30/13 and a discard after date of 05/21/13.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
- Manufacturer
- Pentec Health
- 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 (1)
- Date: 04/30/13 Discard After: 05/21/13
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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