Oasis Medical Recalls HPMC Visoelastic Topical Due to pH Specification Failure
Oasis Medical, Inc. is recalling HPMC Visoelastic Topical products because the pH may not meet specifications at expiry.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a potential failure to meet pH specifications at expiry, a documentation and quality control issue without reported injuries.
Plain-English summary
Oasis Medical, Inc. is recalling HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe. The recall involves 3,358 units distributed nationwide and in several international locations, including Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, and Belgium.
The recall was initiated because it has been determined that the pH of the recalled lots may not meet specification at expiry. The affected lots are V1014M (Exp 10/2016), V1214B (Exp 12/2016), and V0415H (Exp 4/2017).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the distributor or the manufacturer for credit or replacement.
The recalled product
- Product
- HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
- Manufacturer
- Oasis Medical, Inc.
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 3,358
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 (6)
- Lot #: V1014M
- Exp 10/2016
- V1214B
- Exp 12/2016
- V0415H
- Exp 4/2017.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Oasis Medical, Inc. 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.
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