Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns
Pentec Health is recalling Baxter LL bag 1.5% Amino Acids 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 under the rubric, particularly given the risk of infection from non-sterile medical products.
Plain-English summary
Pentec Health Inc. is recalling Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids) in 1000mL, 2000mL, 2500mL, 5000mL, and 6000mL bags. The recall was initiated because sterility could not be assured for these compounded sterile renal nutritional prescriptions.
The affected products were distributed to dialysis centers and directly to patients. The specific compounding dates for the recalled units are April 24, 2013, and April 29, 2013, with discard after dates of May 21, 2013, and May 22, 2013.
Patients and healthcare providers should stop using the affected products and contact their healthcare provider for further instructions.
The recalled product
- Product
- Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
- Manufacturer
- Pentec Health
- Hazard
- Affected units
- 8
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 (3)
- Compounding Date: 04/24/13
- 04/29/13 Discard after: 5/21/13
- 05/22/13
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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