🔍 RecallPedia

Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.

Class I - Dangerous
🏥 Medical Devices Recalled: November 5, 2014 Custom Healthcare Systems Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15
  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:
Custom Healthcare Systems, Inc.
Reason for Recall:
An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior sealed STERILE KIT is correct and NO adverse issues affect that part of the item. The NON-STERILE OUTSIDE "PIGGYBACKED" PACKAGE mistakenly contains ITEM #8881579121 - Syringe prefilled, Saline Flush, 09% Sodium Chloride and is a NONSTERILE PRODUCT that CANNOT BE DROPPED INTO THE STERILE FIELD.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.

Product Codes/Lot Numbers:

Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15

Distribution:

Distributed in: US, CT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2096-2015

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