Pentec Health Recalls Intradialytic Parenteral Nutrition Bags Due to Sterility Concerns
Pentec Health is recalling specific lots of IDPN dialysate solution bags because sterility could not be assured. The products were distributed to dialysis centers and directly to patients.
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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization reports are classified as Severe (4). While specific injury reports are not detailed in the provided snippet, the classification of a sterile medical product where sterility is not assured falls under the higher risk tier for Class II.
Plain-English summary
Pentec Health Inc. is recalling specific lots of IDPN (Intradialytic Parenteral Nutrition) bags. The affected products are dialysate solutions with added amino acids in 490mL, 500mL, and 590mL bag sizes. The recall is due to a lack of assurance of sterility for these compounded sterile renal nutritional prescriptions.
The affected lots have specific compounding and discard dates: the 490mL bags were compounded on April 25, 2013, with a discard date of May 20, 2013. The 500mL and 590mL bags were compounded on April 24, 2013, with a discard date of May 15, 2013. These products were distributed to dialysis centers and directly to patients.
Consumers and healthcare providers should stop using the affected products and contact Pentec Health or their healthcare provider for further instructions. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, 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 (3)
- Compounding Date: a) 04/25/13
- b) 04/24/13 Discard After: a) 05/20/13
- b) and c) 05/15/13
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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