Teleflex Medical recalls Visistat 35 devices where some boxes contain regular devices labeled as wide. This affects laceration closure products.
Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.
Teleflex Medical is recalling Visistat 35 devices because some boxes incorrectly label regular devices as 'Wide' devices. This could lead to using the wrong device type for laceration closure.
The hazard involves some boxes being labeled as 'Visistat Wide' but containing regular devices instead. The 6 individually packaged units within the boxes are correctly labeled, so the issue is with the box labeling.
People who purchased or use Teleflex Medical Visistat 35 devices for laceration closure may be affected. Those using the devices for skin closure are most at risk.
Check if your box is labeled as 'Visistat Wide' but contains regular devices. The product is used for external skin closure of l's. Lot number 73H160:207 is associated with this recall.
Verify if the box is labeled as 'Visistat Wide' but contains regular devices.
The recall is because some boxes are labeled as 'Visistat Wide' devices but contain regular devices instead, even though the individual units are correctly labeled.
The official notice does not specify a remedy, so check the box labeling to ensure you have the correct device type.
The recall describes a labeling issue but does not indicate a risk of serious injury, so the danger level is low risk.
We’ve drafted a message you can send Teleflex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1193-2018 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-1193-2018 from Teleflex 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.
