PORT-A-CATH¿ II POWER P — Class II medical device recall Z-2499-2020
Terminated recall by Smiths Medical ASD Inc., reported 2020-07-15, distributed in AR, CT, MS, TN, TX. Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-
| Recall number | Z-2499-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2020-06-11 |
| Classified | 2020-07-04 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2021-01-25 |
| Distributed | AR, CT, MS, TN, TX |
| Quantity | 46 kits |
| Lot numbers | 3921849 |
Product
PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
Reason for recall
Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.
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-2499-2020. 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.