AMS-636 recall
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Why was AMS-636 recalled?
Incorrect priming volume printed on the device package.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1610092D 1611091D 1612068D 1612074D
- Product
- AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
- Recalling firm
- Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
- Quantity
- 30,700
- Distribution
- US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
- Recall date
- March 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)