Medline Industries, LP
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
SKU DYNDA2705 UDI-DI (ea) 10193489468632 UDI-DI (case) 40193489468633 Kit lots 24DBL787 24HBR630 25ABH699 25DBV209 25GBQ405 SKU DYNJ63347A UDI-DI (ea) 10193489278064 UDI-DI (case) 40193489278065 Kit lots 24AMC874 24AME139 24AMH820 24BMF097 24CMF691 24GMB769 24GMK036 24IMC124 24LMA110 25AMJ634 25GMD386 25IMB510 25JMI708
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →