Recalls / Class II
Class IID-1428-2015
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
- Affected lot / code info
- Lot #: 151900249M, Exp 09/09/15
Why it was recalled
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 120 cassettes
- Distribution pattern
- VA, IL, PA, ID
Timeline
- Recall initiated
- 2015-07-21
- FDA classified
- 2015-09-10
- Posted by FDA
- 2015-09-16
- Terminated
- 2015-09-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1428-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.