# K900585: Tubing Sets for Baxa Exacta-Med Pharmacy Pump

- Pathway: 510(k) (Traditional)
- Applicant: Baxa Corp., Sub. of Cook Group, Inc.
- Decided: Apr 18, 1990 after 70 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 37 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has 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.

## Most influential descendants
- K173577: Guarded Luer Connector (2018), 0 descendants of its own

## Recalls of this device
- Sep 18, 2019 · Class II · Z-0167-2020: Potential ability to leak once used for compounding.
- Sep 12, 2018 · Class II · Z-0364-2019: Potential ability to leak once used for compounding.
- Sep 12, 2018 · Class II · Z-0367-2019: Potential ability to leak once used for compounding.
- Sep 12, 2018 · Class II · Z-0363-2019: Potential ability to leak once used for compounding.
- Sep 12, 2018 · Class II · Z-0366-2019: Potential ability to leak once used for compounding.
- Sep 12, 2018 · Class II · Z-0365-2019: Potential ability to leak once used for compounding.
- Aug 24, 2016 · Class I · Z-0007-2017: Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be
- Aug 22, 2013 · Class II · Z-2165-2013: Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.
- Mar 8, 2011 · Not classified · Z-1963-2011: TPN bags may leak during filling operation, due to bag manufacturing error.
- Mar 8, 2011 · Not classified · Z-1965-2011: TPN bags may leak during filling operation, due to bag manufacturing error.
- Mar 8, 2011 · Not classified · Z-1962-2011: TPN bags may leak during filling operation, due to bag manufacturing error.
- Mar 8, 2011 · Not classified · Z-1964-2011: TPN bags may leak during filling operation, due to bag manufacturing error.
- Mar 8, 2011 · Not classified · Z-1966-2011: TPN bags may leak during filling operation, due to bag manufacturing error.
- Mar 8, 2011 · Not classified · Z-1967-2011: TPN bags may leak during filling operation, due to bag manufacturing error.
- May 26, 2010 · Not classified · Z-2142-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- May 26, 2010 · Not classified · Z-2138-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- May 26, 2010 · Not classified · Z-2141-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- May 26, 2010 · Not classified · Z-2140-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- May 26, 2010 · Not classified · Z-2146-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- May 26, 2010 · Not classified · Z-2148-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- May 26, 2010 · Not classified · Z-2137-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- May 26, 2010 · Not classified · Z-2145-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- May 26, 2010 · Not classified · Z-2143-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- May 26, 2010 · Not classified · Z-2139-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- May 26, 2010 · Not classified · Z-2147-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- May 26, 2010 · Not classified · Z-2144-2010: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- Nov 12, 2009 · Not classified · Z-1030-2010: TPN bags may leak fluid due to inadequate sealing.
- Nov 12, 2009 · Not classified · Z-1031-2010: TPN bags may leak fluid due to inadequate sealing.
- Nov 12, 2009 · Not classified · Z-1032-2010: TPN bags may leak fluid due to inadequate sealing.
- May 8, 2009 · Not classified · Z-1420-2012: Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
- Apr 30, 2004 · Not classified · Z-0979-04: A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
- Apr 30, 2004 · Not classified · Z-0978-04: A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
- Apr 30, 2004 · Not classified · Z-0981-04: A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
- Apr 30, 2004 · Not classified · Z-0983-04: A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
- Apr 30, 2004 · Not classified · Z-0980-04: A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
- Apr 30, 2004 · Not classified · Z-0982-04: A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
- Apr 30, 2004 · Not classified · Z-0984-04: A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.

Source page: https://510kreport.com/device/K900585
Methodology: https://510kreport.com/methodology