🔍 RecallPedia

Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06

Class I - Dangerous
🏥 Medical Devices Recalled: February 25, 2021 Dutch Ophthalmic USA Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Dutch Ophthalmic USA, Inc.
Reason for Recall:
Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281.B1D06
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06

Product Codes/Lot Numbers:

Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757

Distribution:

Distributed in: US, IL, IN, MO, PA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2091-2021

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