Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AMS-636 Recalled by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. Due to Incorrect priming volume printed on the device package.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. directly.
Affected Products
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Quantity: 30,700
Why Was This Recalled?
Incorrect priming volume printed on the device package.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report