CLASS II Device recall · Reported 29 Mar 2017 · FDA Enforcement Report
AMS-636, 60" Microbore extension set recalled by Vygon MFG, Inc
Vygon MFG Inc is recalling AMS-636, 60" Microbore extension set, distributed nationwide in the US. The recall was initiated on 20 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1484-2017
- FDA event ID
- 76607
- Recalling firm
- Vygon MFG Inc, Dover, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Feb 2017
- FDA classified
- 18 Mar 2017
- Reported
- 29 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 20 Feb 2017 | Recall initiated by company | |
| 18 Mar 2017 | Classified by FDA | +26 days |
| 29 Mar 2017 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect priming volume printed on the device package.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Where it was distributed
US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
Nationwide FloridaIllinoisMassachusettsMichiganNew JerseyNew YorkOhioPennsylvaniaTexasVirginiaWashingtonWest Virginia
Questions about this recall
Why was it recalled?
Incorrect priming volume printed on the device package.
Which lots are affected?
1610092D 1611091D 1612068D 1612074D
Where was it sold?
US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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