Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 21-8011-24: 1971567 1979805 1984078 1997124 2006124 2038001 2090898 2151160 2196530 2216256 2249695 21-8052-24: 1971572 2012472 2022904 2067947 2080704 2146472 2168988 2196532 2207404 2237458 2249696 2269178 2282158 21-8053-24: 2168989 2249697
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Smiths Medical ASD, Inc.
- Reason for Recall:
- Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.
Product Codes/Lot Numbers:
21-8011-24: 1971567 1979805 1984078 1997124 2006124 2038001 2090898 2151160 2196530 2216256 2249695 21-8052-24: 1971572 2012472 2022904 2067947 2080704 2146472 2168988 2196532 2207404 2237458 2249696 2269178 2282158 21-8053-24: 2168989 2249697
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2269-2013
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