The Recall Desk
LowFDA (Drugs)·D-0524-2016·Announced 2015-12-30

Oasis Medical Recalls HPMC Visoelastic Due to Potential pH Specification Failure

Oasis Medical is recalling HPMC Visoelastic syringes because the pH may not meet specifications at expiry. The recall covers 14,852 units distributed nationwide and internationally.

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 FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or specification issues without reported harm.

Plain-English summary

Oasis Medical, Inc. is recalling 14,852 units of HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe. The recall is due to a failure in pH specification, as it has been determined that the pH of the affected lots may not meet specification at expiry.

The affected lots include V0814C, V0814D, V1014A, V1014B, V1214C, V0115A, V0115B, V0215C, V0315C, V0315D, V0515A, and V0515B, with expiration dates ranging from August 2016 to May 2017. These products were distributed nationwide and to 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 FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected lots and contact Oasis Medical for further instructions or returns.

The recalled product

Product
HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (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 / Viscoelastic
Hazard
Affected units
14,852

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 #: V0814C
  • V0814D
  • Exp 8/2016
  • V1014A
  • V1014B
  • Exp 10/2016
  • V1214C
  • Exp 12/2016
  • V0115A
  • V0115B
  • Exp 01/2017
  • V0215C
  • Exp 02/2017
  • V0315C
  • V0315D
  • Exp 03/2017
  • V0515A
  • V0515B
  • 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 failure

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