The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1155-2015·Announced 2015-07-08

Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

Lincare, Inc. is recalling specific TPN 3:1 bags because their sterility is not assured. The affected products were compounded in May 2015 and distributed in Arkansas.

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 and involves a lack of assurance of sterility for an intravenous product, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

Lincare, Inc. is recalling 4 bags of TPN 3:1, 997 ml with lipids. The recall is due to a lack of assurance of sterility, meaning the sterility of the product is not assured. The affected product is a prescription-only total parenteral nutrition solution containing dextrose, Travasol, Intralipid, electrolytes, vitamins, and trace elements.

The recall covers all product compounded between May 14, 2015, and May 27, 2015. These products were distributed in the United States, specifically in Arkansas, through United Medical IV Center in Little Rock. The agency has classified this recall as Class II.

Consumers who have these specific TPN bags should stop using them and contact their healthcare provider or Lincare, Inc. for instructions on how to return or dispose of the product. Do not use the product if you are unsure whether it is part of this recall.

The recalled product

Product
TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx…
Manufacturer
Lincare, Inc.
Category
Drug — IV Nutrition
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 (3)

  • All product compounded between May 14
  • 2015 and May 27
  • 2015

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 54 recalled by Lincare, Inc. 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 54 products in this recall →

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