🔍 RecallPedia

LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage

Class I - Dangerous
🏥 Medical Devices Recalled: March 25, 2014 Hospira Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    List No. 4693-04-01 (4693-01); Lot Numbers: 16119NS, 17186NS, 21134NS, 25129NS
  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:
Hospira Inc.
Reason for Recall:
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage

Product Codes/Lot Numbers:

List No. 4693-04-01 (4693-01); Lot Numbers: 16119NS, 17186NS, 21134NS, 25129NS

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1623-2014

Related Recalls

Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

Hospira

Class I - Dangerous

Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy.

Feb 19, 2013 Other Medical Devices Nationwide View Details →