Smiths Medical recalls PORT-A-CATH II Power PAC Low Profile System with 8Fr catheter instead of 6Fr. Affected units may cause complications during procedures.
Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.
Smiths Medical is recalling a specific lot of PORT-A-CATH II Power PAC Low Profile System because it was shipped with an 8Fr catheter instead of the required : 6Fr catheter. Using this incorrect size catheter could lead to complications during medical procedures.
The system was packaged with an 8Fr catheter instead of the required 6Fr catheter. This size difference could cause complications during medical procedures, such as improper insertion or increased risk of complications.
Healthcare professionals using the PORT-A-CATH II Power PAC Low Profile System are likely affected. Patients receiving procedures with this specific lot number may be at risk.
Check for the lot number 3921849 on the PORT-A-CATH II Power PAC Low Profile System packaging. The affected product includes a specific SKU: 21-4477-24.
Look for the lot number 3921849 on the PORT-A-CATH II Power PAC Low Profile System packaging.
Smiths Medical became aware that one lot of PORT-A-CATH II Power PAC Low Profile System was packaged with an 8Fr catheter instead of the required 6Fr catheter.
The recall record does not specify a remedy or action steps for affected units.
The recall record does not describe a hazard that could cause serious injury in normal use.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2499-2020 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2499-2020 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.
