Reported Oct 3, 2012 · Terminated
Biliary Catheters (Models A47XX and CB0XXXXX)
Applied Medical Resources Corp.
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: Applied Medical Resources Corp · 22872 Avenida Empresa # 3 · Rancho Santa Margarita, CA · 92688-2650
Is this the product you have?
Biliary Catheters (Models A47XX and CB0XXXXX)
6 of 6 products
| # | Product as published |
|---|---|
| 1 | Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER |
| 2 | A4754, SYNTEL BILIARY 5F-40CM CATHETER |
| 3 | A4762, SYNTEL BILIARY 6F-23CM CATHETER |
| 4 | CB052308, SYNTEL BILIARY 5F-23CM CATH |
| 5 | CB054008, SYNTEL BILIARY 5F-40CM CATH |
| 6 | CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system. |
- Lot codes and dates
- Model NumbersLot
- Numbers A47521165670
- A47541156762
- A4762
11558521165674
- CB0523081164350
- CB0540081164305
- CB0623131164306
- Amount recalled
- 40,238 units for all products in Recall Event
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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