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
Reported: July 25, 2018 Initiated: June 12, 2018 #D-0944-2018
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: Potential leakage of bags.
Details
- Recalling Firm
- Avella of Deer Valley, Inc. Store 38
- Units Affected
- 15 cassettes
- Distribution
- Nationwide in the USA
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Avella of Deer Valley, Inc. Store 38. Units affected: 15 cassettes.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Potential leakage of bags.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 25, 2018. Severity: Moderate. Recall number: D-0944-2018.
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