FDA Enforcement
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.
Recall: Z-0152-2016
·
Reported October 28, 2015
Enforcement
- Recall Number
- Z-0152-2016
- Event ID
- 72112
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Smiths Medical ASD, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 28, 2015
- Initiation Date
- September 14, 2015
- Classification Date
- October 21, 2015
- Termination Date
- May 9, 2016
- Address
- 1265 Grey Fox Rd, N/A, Saint Paul, MN, 55112-6929, United States
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
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.
Code Info
Lot 46262
Distribution
Worldwide Distribution: US (nationwide) to CA only and countries of: Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland.
Quantity
130 Cartons (1560 needles)