Recall Z-1073-2018— Smiths Medical ASD Inc.
Class II · Terminated
Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2017-12-04, terminated 2020-06-12. It names 2 FDA 510(k) clearances: K974471, K973862. Product: 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). Reason: 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..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-04
- Terminated
- 2020-06-12
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K974471 — PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A
- K973862 — PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.