Reported Mar 21, 2018 · Terminated
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as
7 of 7 products
| # | Product as published |
|---|---|
| 1 | VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA) |
| 2 | VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA) |
| 3 | VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA) |
| 4 | DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA) |
| 5 | DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA) |
| 6 | DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA) |
| 7 | DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA) |
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Product as published 21-4474-24(Lot No. 87X040, 87X117) 21-4475-24(Lot No. 87X044) 21-4477-24(Lot No. 87X097) 21-8466-24(Lot No. 87X171) 21-8468-24(Lot No. 87X172, 87X244, 87X180) 21-8469-24(Lot No. 87X151) 21-8470-24(Lot No. 87X173, 87X254, 87X194, 87X198, 87X237) - Amount recalled
- 1,077 units total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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