Avella Recalls Ropivacaine Pumps Due to Potential Sterility Compromise
Avella of Deer Valley is recalling 40 Ropivacaine OnQ pumps due to potential bag leakage that compromises sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the potential for serious infection from a non-sterile medical device in a surgical context warrants a high severity rating consistent with the agency's classification.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 40 units of 0.2% Ropivacaine OnQ pumps. The product is a single-dose pump containing Ropivacaine HCL and Sodium Chloride, manufactured for Vidant Medical Center. The recall is being conducted because of a lack of assurance of sterility, specifically due to potential leakage of the bags.
The affected lots are identified by the codes 5/14/18 0749 525-66102 (Best Use Date 6/13/2018) and 5/22/18 0837 495-66102 (Best Use Date 6/21/2018). The product was distributed nationwide in the USA. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients who have received these specific pumps should stop using them and contact Avella of Deer Valley or their healthcare provider for instructions on return or replacement. Consumers should not use the product if they suspect the bag is leaking or if the sterility seal is compromised.
The recalled product
- 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: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Anesthetic
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # 5/14/18 0749 525-66102
- BUD 6/13/2018
- 5/22/18 0837 495-66102
- BUD 6/21/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 38 recalled by Avella of Deer Valley, Inc. Store 38 under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 38 products in this recall →Related recalls
Same manufacturer · Avella of Deer Valley, Inc. Store 38
See all →- SevereAvella Recalls Povidone Iodine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2019-10-30
- SevereAvella Recalls Bevacizumab Prefilled Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-06-05
- ModerateAvella recalls magnesium sulfate bags with incorrect barcode expiration dates
FDA (Drugs) · 2019-02-20
- ModerateAvella Recalls Labetalol Syringes Due to Incorrect Barcode Expiration Dates
FDA (Drugs) · 2019-02-20
- ModerateAvella recalls magnesium sulfate bags with incorrect barcode expiration dates
FDA (Drugs) · 2019-02-20
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12