FDA-Device2015-10-28Class II
PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with standard luer lock connectors.
Smiths Medical ASD, Inc.
Hazard
The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The part number should be 21-2287-24 Port-A-Cath Plastic Hub Bent Needle.
Sold states
Worldwide Distribution: US (nationwide) to CA only and countries of: Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland.
Affected count
130 Cartons (1560 needles)
Manufactured in
1265 Grey Fox Rd, N/A, Saint Paul, MN, United States
Products
PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with standard luer lock connectors.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2016Don't want to check this manually?
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