Smiths Medical recalls PORT-A-CATH II PS/Titan and Tray PAC II kits that may have incorrect 6Fr/6.5Fr introducers instead of 8.5Fr. This could cause improper catheter placement 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 certain PORT-A-CATH II PS/Titan and Tray PAC II kits that may have been misassembled with the wrong introducer size (6Fr or 6.5Fr instead of 8.5Fr). This could lead to improper catheter placement during medical procedures, potentially causing complications.
The kits may contain a 6Fr or 6.5Fr introducer instead of the correct 8.5Fr size. This mismatch could cause improper catheter placement during medical procedures, potentially leading to complications like infection or incorrect positioning.
Healthcare providers using these specific kits for medical procedures are most at risk. Patients receiving procedures with these kits could face complications due to incorrect catheter placement.
Check for the specific item numbers and lot numbers listed: Item No. 21-4071-24 (Lot No. 86X046, 87X050), Item No. 21-8066-24 (Lot No. 87X178), or Item No. 21-8068-24 (Lot No. 87X179).
Verify the item number and lot number on the kit packaging to determine if it's affected.
The kits may contain a 6Fr or 6.5Fr introducer instead of the correct 8.5Fr size, which could cause improper catheter placement during medical procedures.
Kits with Item No. 21-4071-24 (Lot No. 86X046, 87X050), Item No. 21-8066-24 (Lot No. 87X178), or Item No. 21-8068-24 (Lot No. 87X179).
The recall record does not specify a remedy, so contact Smiths Medical directly 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-1073-2018 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1073-2018 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.
