Agency classClass IIOur severity:High FDA (Drugs)·D-0613-2016·Announced 2016-02-03

Sentara Recalls Sodium Chloride Homepumps Due to Sterility Concerns

Sentara Enterprises is recalling specific lots of Sodium Chloride Homepumps because the sterility of the product cannot be guaranteed.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen risk (lack of sterility assurance) for an intravenous product, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Sentara Enterprises is recalling specific lots of Sodium Chloride (SOD CHLORIDE) packaged in Homepumps. The affected products include various concentrations (0.9% and 0.45%) and volumes (30ml, 218ml, 500ml, 1500ml, and 1920ml). These products were compounded between September 11, 2015, and September 17, 2015, and are distributed in Virginia and North Carolina.

The recall was initiated because the sterility of the product cannot be guaranteed. This lack of assurance of sterility presents a potential risk to patients using the intravenous solution.

Patients and healthcare providers should stop using the affected lots immediately. Consumers should check their medication labels for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled description, it should be returned to the pharmacy or healthcare provider for disposal or replacement.

The recalled product

Product: SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy…
Manufacturer: Sentara Enterprises
Category: Drug — IV Solution
Hazard: sterility
infection

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 (6)

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 28-Sep-15
1-Oct-15
b) 22-Sep-15
c) 30-Sep-15 d) 29-Sep-15
e) 25-Sep-15
f) 28-Sep-15

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 34 recalled by Sentara Enterprises 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 34 products in this recall →

Same manufacturer · Sentara Enterprises

See all →

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Sentara Recalls Compounded Cancidas Due to Sterility Concerns
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Same hazard · sterility