Beaver Visite: Malosa Core SMILE Pack 2 medical refractive kits with packaging holes may compromise sterility. Affected kits include specific lot numbers for cataract, corneal, or refractive surgery procedures.
Kit packaging may have small holes compromising product sterility
Beaver Visitec recalls Malosa Core SMILE Pack 2 medical kits used in eye surgery due to potential packaging holes that could compromise sterility. This risk means the kits might not be safe for surgical procedures if used without proper sterilization.
The packaging may have small holes that could allow contaminants to enter the sterile kit. This might compromise the sterility of the medical instruments, increasing the risk of infection during surgery.
Medical professionals using the Malosa Core SMILE Pack 2 kits for cataract, corneal, or refractive surgery procedures. Patients undergoing these surgeries are at risk if the kits are used without proper sterility.
Check for the product name 'Malosa Core SMILE Pack 2' and lot numbers 3347922, 3350452, 3354937, 3358047, or 3364371. The kits are intended for use in eye surgery procedures.
Inspect the packaging for small holes that might compromise sterility.
The packaging may have small holes that could allow contaminants to enter, potentially compromising sterility during surgery.
Lot numbers 3347922, 3350452, 3354937, 3358047, and 3364371.
The recall does not require immediate discontinuation; check for packaging holes before use.
We’ve drafted a message you can send Beaver Visitec to request your refund or repair — edit it as you like.
Subject: Recall Z-0410-2022 — Beaver Visitec Beaver Visitec Hello, I own a Beaver Visitec that is covered by recall Z-0410-2022 from Beaver Visitec. 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.