CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
Port-a-cath II PS/Titan, Tray PAC II recalled by Smiths Medical ASD
Smiths Medical ASD is recalling Port-a-cath II PS/Titan, Tray Pac II. Labeled as: a. Ven LP, PU, UL, 8./Intro (1/EA), distributed nationwide in the US. The recall was initiated on 4 Dec 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1073-2018
- FDA event ID
- 79429
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Dec 2017
- FDA classified
- 15 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Dec 2017 | Recall initiated by company | |
| 15 Mar 2018 | Classified by FDA | +101 days |
| 21 Mar 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
Where it was distributed
Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.
Questions about this recall
Why was it 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.
Which lots are affected?
a. Item No. 21-4071-24 (Lot No. 86X046, 87X050); b. Item No. 21-8066-24 (Lot No. 87X178); c. Item No. 21-8068-24 (Lot No. 87X179)
Where was it sold?
Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 79429| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Power Port-a-cath II, Tray Power Pac II recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
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