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
Reported: September 16, 2015 Initiated: July 21, 2015 #D-1428-2015
Product Description
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.
Details
- Recalling Firm
- Pharmedium Services, LLC
- Units Affected
- 120 cassettes
- Distribution
- VA, IL, PA, ID
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pharmedium Services, LLC. Units affected: 120 cassettes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 16, 2015. Severity: Moderate. Recall number: D-1428-2015.
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