The Recall Desk
SevereFDA (Drugs)·D-0611-2020·Announced 2019-12-18

Surgery Pharmacy Services Recalls Trisodium Citrate CRRT Solution for Sterility Concerns

Surgery Pharmacy Services is recalling 84 bags of Trisodium Citrate 0.5% CRRT Solution due to a lack of sterility assurance. The product was distributed in Georgia and Tennessee.

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. According to the rubric, an FDA Class II recall with potential for adverse health consequences (lack of sterility assurance) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High (3) due to the agency's specific classification of the risk.

Plain-English summary

Surgery Pharmacy Services Inc is recalling 84 bags of Trisodium Citrate 0.5% CRRT Solution. The recall was initiated because the product lacks sterility assurance. The solution is a prescription-only medication mixed by Surgery Pharmacy Services in Chattanooga, Tennessee, and is intended for continuous renal replacement therapy (CRRT).

The affected product consists of patient-specific volumes with Rx numbers ranging from 311976 to 314888. These bags were distributed in Georgia and Tennessee. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Patients who have received this specific solution should contact their healthcare provider for further instructions. No specific dates or additional distribution details are provided in the source text.

The recalled product

Product
Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409
Affected units
84

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)

  • RX numbers from 311976 to 314888

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Surgery Pharmacy Services 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 2 products in this recall →

Same manufacturer · Surgery Pharmacy Services Inc

See all →