0.2% ROPivacaine - OnQ Pump recall: Sterility Concern
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…
Why was 0.2% ROPivacaine - OnQ Pump recalled?
Lack of Assurance of Sterility: Potential leakage of bags.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 5/14/18 0749 525-66102, BUD 6/13/2018; 5/22/18 0837 495-66102, BUD 6/21/2018
- Product
- 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…
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
- Quantity
- 40 pumps
- Distribution
- Nationwide in the USA
- Recall date
- July 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)