SPS Sterilization recalls Vascular Solutions Venture Rx 6F catheters with resterilized labels due to shelf life expiration. The device may expire before its validated shelf life, risking potential use issues.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
SPS Sterilization is recalling Vascular Solutions Venture Rx 6F catheters that were resterilized. The issue is that the expiration date on the device labeling exceeds its actual validated shelf life, which could lead to potential use problems if the catheter is used after its safe shelf life.
The catheter's expiration date on the labeling is past its actual validated shelf life because the sterilization process used does not support extended shelf life. This could lead to potential use issues if the catheter is used after its safe shelf life period.
Healthcare professionals using the Vascular Solutions Venture Rx 6F catheters with resterilized labels are most at risk. Patients receiving these catheters may be affected if the device is used after its validated shelf life.
Check for the model 'Vascular Solutions Venture Rx Catheter, 6F, resterilized' with specific lot numbers: 570183 (serial 99804132016-07) or 583022 (serials 17304202017-07 or 17304202017-08).
Verify the expiration date on the device labeling against the validated shelf life period.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for extended shelf life.
Check the label expiry date against the validated shelf life period. If it has expired, stop using it.
Look for the model 'Vascular Solutions Venture Rx Catheter, 6F, resterilized' with lot numbers 570183 (serial 99804132016-07) or 583022 (serials 17304202017-07 or 17304202017-08).
We’ve drafted a message you can send SPS Sterilization to request your refund or repair — edit it as you like.
Subject: Recall Z-3041-2018 — SPS Sterilization SPS Sterilization Hello, I own a SPS Sterilization that is covered by recall Z-3041-2018 from SPS Sterilization. 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.
