Smiths Medical recalls Power PORT-A-CATH II and TRAY POWER PAC II kits with incorrect 6Fr/6.5Fr introducers instead of 8.5Fr. Affected kits may cause complications during medical procedures.
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.
Smiths Medical is recalling Power PORT-A-CATH II and TRAY POWER PAC II kits that may contain incorrectly sized introducers (6Fr or 6.5Fr instead of 8.5Fr) or wrong locking collars. Using these kits could lead to complications during medical procedures because the wrong size might not fit properly.
The kits may have been misassembled with a 6Fr or 6.5Fr introducer instead of the correct 8.5Fr size. This could cause improper fitting during medical procedures, potentially leading to complications like dislodgement or infection.
Patients receiving hemodialysis or other medical treatments using these specific kits are most at risk. Healthcare providers who use the recalled kits for implantable port systems should check their equipment.
Check for the product labels: VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA) or VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA). Affected kits have specific item numbers and lot numbers listed in the recall notice.
Look for the product labels and item numbers listed in the recall notice to confirm if your kit is affected.
Reach out to Smiths Medical directly for assistance with the recall process.
The kits may contain incorrectly sized introducers (6Fr or 6.5Fr instead of 8.5Fr) or wrong locking collars, which could cause improper fitting during medical procedures.
Check the product labels and item numbers listed in the recall notice. Affected kits have specific item numbers and lot numbers like 21-4474-24 (Lot No. 87X040, 87X117).
No, but you should check if your kit is affected and contact Smiths Medical for guidance.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1074-2018 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1074-2018 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
