Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48

FDA recall notice · announced September 16, 2015 · Pharmedium Services

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48

Reason for recall

Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.

Notes

Distribution: VA, IL, PA, ID
Lot/code information: Lot #: 151900249M, Exp 09/09/15
Quantity: 120 cassettes
Status: Terminated
Products in this recall event:
- Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48 (D-1428-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.