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
Reported: July 25, 2018 Initiated: June 12, 2018 #D-0928-2018
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.
Details
- Recalling Firm
- Avella of Deer Valley, Inc. Store 38
- Units Affected
- 40 pumps
- Distribution
- Nationwide in the USA
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Avella of Deer Valley, Inc. Store 38. Units affected: 40 pumps.
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-0928-2018.
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