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Recall Observatory FDA recall evidence

Device product

The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.

Z-1570-2022

July 14, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90643
Status
Ongoing
Classification
Class II
Quantity
448,960 units
Official record key
device-enforcement:Z-1570-2022

Official wording

Reason: There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.

Code information: Product Code: H938724 Lot Number 60316024 and higher; expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183

Distribution pattern: Worldwide distribution: US Nationwide, Canada, Uruguay, Argentina, Brazil, Colombia, Dominican Republic, Panama, Puerto Rico, Hong Kong, Taiwan, Korea, United Kingdom, Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Kuwait, Netherlands, Oman, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.