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Recall Observatory FDA recall evidence

Drug 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

D-1428-2015

July 21, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 71892
Status
Terminated
Classification
Class II
Quantity
120 cassettes
Official record key
drug-enforcement:D-1428-2015

Official wording

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

Code information: Lot #: 151900249M, Exp 09/09/15

Distribution pattern: VA, IL, PA, ID

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility