D-0928-2018 Class II Terminated
FDA drug recall D-0928-2018 was initiated by Avella Of Deer Valley, Inc. Store 38 on Jun 12, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Potential leakage of bags. The recall status is terminated (terminated Jan 24, 2020). Affected quantity: 40 pumps.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 25, 2018
- Initiation Date
- Jun 12, 2018
- Termination Date
- Jan 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 pumps
Product Description
0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02
Reason for Recall
Lack of Assurance of Sterility: Potential leakage of bags.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 5/14/18 0749 525-66102, BUD 6/13/2018; 5/22/18 0837 495-66102, BUD 6/21/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0928-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026