Medline Industries is recalling 1,093 units of various sterile convenience kits, including Craniotomy Packs, Pediatric Craniotomy/Laminectomy Kits, and Anesthesia Turnover Kits. These sterile kits were distributed with a non-sterile Mastisol liquid adhesive component that was not clearly labeled as non-sterile. This defect could lead medical professionals to mistakenly believe the adhesive is sterile during surgical procedures. The kits were distributed in Texas, Illinois, and California.
If a healthcare provider assumes the Mastisol component is sterile and uses it in a sterile field or on a surgical site, there is a significantly increased risk of introducing contaminants, which can lead to serious patient infection.
Contact healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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