Exactamix H938737

• FDA 510(k) K900585 decided 18 Apr 1990 Active
• FDA GUDID UDI-DI 00085412477213 listed 24 Sep 2016 Listed

• 6 recalls, same reason

  • Terminated Z-0167-2020 FDA Class II ·initiated 18 Sep 2019
  • Terminated Z-0364-2019 FDA Class II ·initiated 12 Sep 2018 ·on shared 510(k) K900585
  • Terminated Z-0365-2019 FDA Class II ·initiated 12 Sep 2018 ·on shared 510(k) K900585
  • Terminated Z-0366-2019 FDA Class II ·initiated 12 Sep 2018 ·on shared 510(k) K900585
  • Terminated Z-0363-2019 FDA Class II ·initiated 12 Sep 2018 ·on shared 510(k) K900585
  • Terminated Z-0367-2019 FDA Class II ·initiated 12 Sep 2018 ·on shared 510(k) K900585

  Potential ability to leak once used for compounding.

• • Terminated Z-0007-2017 FDA Class I ·initiated 24 Aug 2016

  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 missing and for particulate matter to be present.

• • Terminated Z-2165-2013 FDA Class II ·initiated 22 Aug 2013

  Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.

• 6 recalls, same reason

  • Terminated Z-1962-2011 FDA Unclassified (pre-2012) ·initiated 8 Mar 2011
  • Terminated Z-1964-2011 FDA Unclassified (pre-2012) ·initiated 8 Mar 2011
  • Terminated Z-1966-2011 FDA Unclassified (pre-2012) ·initiated 8 Mar 2011
  • Terminated Z-1967-2011 FDA Unclassified (pre-2012) ·initiated 8 Mar 2011
  • Terminated Z-1965-2011 FDA Unclassified (pre-2012) ·initiated 8 Mar 2011
  • Terminated Z-1963-2011 FDA Unclassified (pre-2012) ·initiated 8 Mar 2011

  TPN bags may leak during filling operation, due to bag manufacturing error.

• 12 recalls, same reason

  • Terminated Z-2148-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585
  • Terminated Z-2144-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585
  • Terminated Z-2143-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585
  • Terminated Z-2145-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585
  • Terminated Z-2138-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585
  • Terminated Z-2140-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585
  • Terminated Z-2146-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585
  • Terminated Z-2142-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585
  • Terminated Z-2139-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585
  • Terminated Z-2147-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585
  • Terminated Z-2141-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585
  • Terminated Z-2137-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K900585

  Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.

• 3 recalls, same reason

  • Terminated Z-1031-2010 FDA Unclassified (pre-2012) ·initiated 12 Nov 2009 ·on shared 510(k) K900585
  • Terminated Z-1030-2010 FDA Unclassified (pre-2012) ·initiated 12 Nov 2009 ·on shared 510(k) K900585
  • Terminated Z-1032-2010 FDA Unclassified (pre-2012) ·initiated 12 Nov 2009 ·on shared 510(k) K900585

  TPN bags may leak fluid due to inadequate sealing.

• • Terminated Z-1420-2012 FDA Unclassified (pre-2012) ·initiated 8 May 2009

  Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.

• 7 recalls, same reason

  • Terminated Z-0978-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2004
  • Terminated Z-0979-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2004
  • Terminated Z-0981-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2004
  • Terminated Z-0982-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2004
  • Terminated Z-0980-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2004
  • Terminated Z-0983-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2004
  • Terminated Z-0984-04 FDA Unclassified (pre-2012) ·initiated 30 Apr 2004

  A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 8 Mar 2011 Recall initiated FDA recalls Z-1963-2011
2. 22 Aug 2013 Recall initiated FDA recalls Z-2165-2013
3. 24 Aug 2016 Recall initiated FDA recalls Z-0007-2017
4. 24 Sep 2016 Listed FDA GUDID 00085412477213
5. 12 Sep 2018 Recall initiated FDA recalls Z-0364-2019
6. 12 Sep 2018 Recall initiated FDA recalls Z-0365-2019
7. 12 Sep 2018 Recall initiated FDA recalls Z-0366-2019
8. 12 Sep 2018 Recall initiated FDA recalls Z-0363-2019
9. 12 Sep 2018 Recall initiated FDA recalls Z-0367-2019
10. 18 Sep 2019 Recall initiated FDA recalls Z-0167-2020

29 earlier events are in the sections above.

Trade name

Exactamix

Generic name

Intravenous administration bag/bottle

Model / Ref / Catalog

H938737

Primary DI / UDI-DI

00085412477213

510(k) Number

K900585 ↗

FDA product code

LHI

GMDN term

Intravenous administration bag/bottle

Device class

Class II

Regulation number

880.5440

GUDID distribution status

In Commercial Distribution

Size

Total Volume — 250 Milliliter

Category: Intravenous administration bag/bottle

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  FDA 510(k) K220558 Active Cleared 17 Nov 2022 GUDID on market

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See all devices from Baxter Healthcare Corp →