The Recall Desk
LowFDA (Drugs)·D-0522-2016·Announced 2015-12-30

Oasis Medical Recalls HPMC Visoelastic Due to pH Specification Failure

Oasis Medical, Inc. is recalling HPMC Visoelastic syringes because the pH of the affected lots 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 by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or specification issues.

Plain-English summary

Oasis Medical, Inc. is recalling 15,301 units of HPMC Visoelastic, 20,000 cps, 2.0 mL in 3-mL Syringe. The recall covers specific lots with expiration dates ranging from August 2016 to May 2017. The product was distributed nationwide and in several international locations, including Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Colombia, 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. This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the affected lots and contact Oasis Medical, Inc. for further instructions or a refund.

The recalled product

Product
HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 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
15,301

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 (19)

  • Lot #: V0814H
  • V0814J
  • Exp 08/2016
  • V1014L
  • Exp 11/2016
  • V1114A
  • V0115G
  • V0115H
  • Exp 01/2017
  • V0215A
  • V0215B
  • Exp 02/2017
  • V0315G
  • V0315H
  • V0315O
  • Exp 03/2017
  • V0515C
  • V0515D
  • Exp 05/2017.

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.

See all 3 products in this recall →

Related recalls

Same manufacturer · Oasis Medical, Inc.

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Same hazard · ph specification

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