Reported Jul 17, 2013 · Terminated
Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85"…
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?
- Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2
- 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
97 of 97 codes
UR175554UR176743UR182030UR188144UR192047UR192096UR192260UR194951UR202044UR204032UR211698UR214312UR216069UR222471UR225334UR229294UR233569UR233700UR238915UR243022UR246009UR249383UR255802UR260273UR262980UR263004UR265918UR283580UR287284UR288746UR298216UR304246UR307249UR314328UR318063UR321000UR325464UR334151UR339317UR344234UR352484UR352567UR360255UR363432UR366161UR375857UR383794UR385534UR07J19029UR07K29059UR07L21039UR08B21053UR08C25151UR08E15157UR08G22167UR08I12065UR08K13086UR08L18158UR09A21211UR09D02157
- Amount recalled
- 356,728 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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