Z-0152-2016 Class II Terminated
FDA device recall Z-0152-2016 was initiated by Smiths Medical ASD, Inc. on Sep 14, 2015 and is designated Class II. 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… The recall status is terminated (terminated May 9, 2016). Affected quantity: 130 Cartons (1560 needles).
Recall Details
- Product Type
- Devices
- Report Date
- Oct 28, 2015
- Initiation Date
- Sep 14, 2015
- Termination Date
- May 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130 Cartons (1560 needles)
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) to CA only and countries of: Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland.
Code Information
Lot 46262
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0152-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026