🔍 RecallPedia

BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.

Class I - Dangerous
🏥 Medical Devices Recalled: November 15, 2016 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Lot Number 1230323, Exp. Date December 2016; Lot Number 1230387, Exp. Date December 2016; Lot Number 1231616, Exp. Date December 2016
  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:
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Reason for Recall:
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.

Product Codes/Lot Numbers:

Lot Number 1230323, Exp. Date December 2016; Lot Number 1230387, Exp. Date December 2016; Lot Number 1231616, Exp. Date December 2016

Distribution:

Distributed in: PA, FL, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0895-2017

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