Medline and Centurion dialysis dressing change kits recalled for defective Tego Connectors
Stop using recalled dialysis dressing kits
Medline Industries is recalling several dialysis and pheresis dressing change kits because the silicone seals on included Tego Connectors may be damaged, domed, or torn. A damaged seal can prevent blood withdrawal or injection, cause fluid leakage, delay treatment, or allow air or contaminants into the bloodstream.
- Check your dialysis or pheresis dressing change kit against the affected SKU and lot numbers listed in the recall notice.
- Stop using any kit with a matching SKU and lot number immediately.
- Contact your dialysis clinic or healthcare provider for replacement kits and guidance.
- Report any problems with these kits to the FDA MedWatch program or call 1-888-MEDLINE.
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1467-2026More Medline Industries, LP recalls
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