Medline apheresis and central line kits recalled over connector seal defects
Medline is recalling Apheresis Subqport Access Kits and Central Line Insertion kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall describing potential therapy interruption and contamination, with no hospitalisations stated in the source.
Plain-English summary
Medline Industries, LP is recalling Medline kits containing Tego Connectors: the Apheresis Subqport Access Kit (SKU DYNDA2705) and the Central Line Insertion kit (SKU DYNJ63347A). About 1,212 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
Affected lots may exhibit issues with the silicone seal on the Tego Connectors, including 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, fluid leakage, interruption in therapy, exposure to biological contaminants, or air infused into the body.
SKU DYNDA2705 carries UDI-DI 10193489468632 (each) and 40193489468633 (case) in kit lots 24DBL787, 24HBR630, 25ABH699, 25DBV209 and 25GBQ405. SKU DYNJ63347A carries UDI-DI 10193489278064 (each) and 40193489278065 (case) across thirteen kit lots beginning 24AMC874.
Facilities can identify affected kits by the SKU, UDI and lot codes above, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
- Manufacturer
- Medline Industries, LP
- Affected units
- 1,212
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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