Power PORT-A-CATH II — Class II medical device recall Z-1074-2018
Terminated recall by Smiths Medical ASD Inc., reported 2018-03-21, distributed nationwide. Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrec
| Recall number | Z-1074-2018 |
|---|---|
| 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 | 2017-12-04 |
| Classified | 2018-03-15 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2020-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BS, DO, ES, NL |
| Quantity | 1,077 units |
| Lot numbers | 87X040, 87X044, 87X097, 87X117, 87X151, 87X171, 87X172, 87X173, 87X180, 87X194, 87X198, 87X237, 87X244, 87X254 |
| Model numbers | 21-4474-24, 21-4475-24, 21-4477-24, 21-8466-24, 21-8468-24, 21-8469-24, 21-8470-24 |
Product
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)
Reason for recall
Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.
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-1074-2018. 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.