Medline Cataract Pack convenience kits recalled for potential open seals compromising sterility
What this means
Some Medline Cataract Pack convenience kits (model DYNJ59881A, Lot 25GBP246) may have open seals in their sterile pouch packaging. An open seal can allow the sterile contents to become contaminated. If a kit with an open seal is used without being detected first, it could introduce infection into the surgical field or patient.
- Check any Medline Cataract Pack kits (DYNJ59881A, Lot 25GBP246) in your facility before use.
- Inspect the sterile pouch seal for any signs of opening or damage.
- Do not use any kit with a compromised or open seal.
- Contact Medline Industries or your supplier for replacement or instructions.
The agency's original wording
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3210-2026More Medline recalls
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