FDA-Drug2018-07-25Class II

fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-250-87

Avella of Deer Valley, Inc. Store 38
Hazard

Lack of Assurance of Sterility: Potential leakage of bags.

Sold states
Nationwide in the USA
Affected count
15 cassettes
Manufactured in
24416 N 19th Ave, Phoenix, AZ, United States
Products
fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-250-87

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0944-2018

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