PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 28, 2015 Initiated: September 14, 2015 #Z-0152-2016

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Smiths Medical ASD, Inc.
Units Affected
130 Cartons (1560 needles)
Distribution
Worldwide Distribution: US (nationwide) to CA only and countries of: Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland.
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Smiths Medical ASD, Inc.. Units affected: 130 Cartons (1560 needles).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 28, 2015. Severity: Moderate. Recall number: Z-0152-2016.