Reported Apr 19, 2017 · Terminated
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
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. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
- Lot codes and dates
46X81746X82946X89946X82846X89646X99046X83146X89746X1001
- Amount recalled
- 38,415 (38145 US; 2268 OUS)
Where it was sold
Why it was recalled
Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns.
This product could cause temporary or reversible health problems — stop using it.
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