Reported Mar 13, 2013 · Terminated
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids…
Churchill Medical Systems, 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: Churchill Medical Systems, Inc. · 87 Venture Drive · Dover, NH · 03820-5914
Is this the product you have?
- Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
- Lot codes and dates
- Lot #1210099
- Amount recalled
- 2340
Where it was sold
Why it was recalled
The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
This product could cause temporary or reversible health problems — stop using it.
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