Reported Oct 2, 2013 · Terminated
Smiths Medical, Deltec
Smiths Medical ASD, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD, Inc. · 1265 Grey Fox Rd · Saint Paul, MN · 55112-6929
Is this the product you have?
Smiths Medical, Deltec
3 of 3 products
| Model / number | Product as published |
|---|---|
21-8011-24 | Port-A-Cath Dual-Lumen. Titanium Venous Access System. |
21-8052-24 | & |
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. |
- Lot codes and dates
- 21-8011-24:21-8052-24:
19715671979805198407819971242006124203800120908982151160219653022162562249695
21-8053-24: 2168989 22496971971572201247220229042067947208070421464722168988219653222074042237458224969622691782282158
- 21-8011-24:
- Amount recalled
- 372
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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