PORT-A-CATH Plastic Hub Needles — Class II medical device recall Z-0152-2016
Terminated recall by Smiths Medical ASD, Inc., reported 2015-10-28, distributed nationwide. The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the in
| Recall number | Z-0152-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Saint Paul, MN, United States |
| Recall initiated | 2015-09-14 |
| Classified | 2015-10-21 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2016-05-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, DE, HU, IT, SE |
| Reason classes | labeling |
| Lot numbers | 46262 |
| Model numbers | 21-2287-24 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0152-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.