# K925126: Interlink (TM) Injection Site

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 18, 1993 after 248 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1269-2013: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
- Dec 6, 2011 · Not classified · Z-0471-2012: During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking 
- Jul 6, 2011 · Not classified · Z-2837-2011: Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
- Dec 15, 2005 · Not classified · Z-0634-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0637-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0641-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0630-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0638-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0640-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0644-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0652-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0629-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0648-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1424-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Jul 6, 2005 · Not classified · Z-1099-05: Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.
- Jul 6, 2005 · Not classified · Z-1102-05: Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.
- Jul 16, 2003 · Not classified · Z-1154-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1151-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1165-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Dec 18, 2002 · Not classified · Z-0450-03: Leakage may occur at the inlet port
- Oct 17, 2002 · Not classified · Z-0505-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0509-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0522-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0517-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0507-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0518-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

Source page: https://510kreport.com/device/K925126
Methodology: https://510kreport.com/methodology