Medline recalls Hystero Pack PVP solution kits with mislabeled sterile packaging that could lead to incorrect medical use. Affected lots include specific model numbers and batch codes.
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Medline is recalling Hystero Pack PVP solution kits that were mislabeled as sterile when they are non-sterile. This could lead to improper medical use if the product is used without understanding its sterility status.
The product was incorrectly labeled as sterile when it is non-sterile. This mislabeling could lead to improper medical use if healthcare providers assume the product is sterile when it is not, potentially causing infections or other complications.
Healthcare providers using Medline Hystero Pack kits with model number DYNJ61448A and lot number 23CBS268 are most at risk. Patients using these kits for medical procedures may be affected if the product is misused.
Check for the model number DYNJ61448A on the Hystero Pack kit. The lot number 23CBS268 is also associated with this recall. Products labeled as "STERILE PVP SLN" instead of "NON-STERILE PVP SOLUTION, STERILE PACKAGING" are affected.
Look for the model number DYNJ61448A and lot number 23CBS268 on the Hystero Pack kit.
The product is non-sterile but has sterile packaging. Using it without understanding its sterility status could lead to improper medical use.
The recall record does not specify a remedy, so check the product label and contact Medline for further instructions.
Check for model number DYNJ61448A and lot number 23CBS268. Products labeled as "STERILE PVP SLN" instead of "NON-STERILE PVP SOLUTION, STERILE PACKAGING" are affected.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2135-2023 — Medline Medline Hello, I own a Medline that is covered by recall Z-2135-2023 from Medline. 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.
