CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report
AMS-651, 120" Microbore extension set with slide clamp recalled
Vygon MFG Inc is recalling AMS-651, 120" Microbore extension set with slide clamp, distributed in California. The recall was initiated on 18 Nov 2016 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-0787-2017
- FDA event ID
- 75816
- Recalling firm
- Vygon MFG Inc, Dover, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Nov 2016
- FDA classified
- 18 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 18 Nov 2016 | Recall initiated by company | |
| 18 Dec 2016 | Classified by FDA | +30 days |
| 28 Dec 2016 | Published in enforcement report | +10 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 is 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-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Where it was distributed
US distribution in the state of CA
Questions about this recall
Why was it recalled?
Incorrect priming volume is printed on the device package.
Which lots are affected?
1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D
Where was it sold?
US distribution in the state of CA
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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