Reported Jul 17, 2013 · Terminated
Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate…
Baxter Healthcare 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: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5
- m) UsageBaxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers
- Lot codes and dates
111 of 111 codes
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
- Amount recalled
- 530,488 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
This product could cause temporary or reversible health problems — stop using it.
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