Pentec Health Recalls Proplete 45-51 KG Due to Sterility Concerns
Pentec Health is recalling Proplete 45-51 KG intraperitoneal 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 agency classification is FDA Class II, and the product is a sterile intraperitoneal solution where a lack of sterility assurance poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Pentec Health Inc. is recalling Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids) in 435mL bags. The recall involves 4 bags with a compounding date of 04/24/13 and a discard after date of 5/15/13.
The recall was initiated due to a lack of assurance of sterility. The source text states that sterility could not be assured for these compounded sterile renal nutritional prescriptions. The product was distributed to dialysis centers and directly to patients.
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
- Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
- Manufacturer
- Pentec Health
- Hazard
- Affected units
- 4
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: 04/24/13 Discard after: 5/15/13
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.
See all 15 products in this recall →Related recalls
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