CLASS II Device recall · Reported 31 May 2017 · FDA Enforcement Report
Corflo, PEG Adaptor Repair Kit with ENFit Connectors, Size recalled
CORPAK MedSystems is recalling Corflo, PEG Adaptor Repair Kit with ENFit Connectors, Size, distributed in California, New Hampshire, Vermont. The recall was initiated on 3 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-2161-2017
- FDA event ID
- 76465
- Recalling firm
- CORPAK MedSystems, Buffalo Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Feb 2017
- FDA classified
- 24 May 2017
- Reported
- 31 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Syringes & Needles
Timeline
| 3 Feb 2017 | Recall initiated by company | |
| 24 May 2017 | Classified by FDA | +110 days |
| 31 May 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
Where it was distributed
Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
Questions about this recall
Is Corflo, PEG Adaptor Repair Kit with ENFit Connectors, Size recalled?
Yes. CORPAK MedSystems recalled Corflo, PEG Adaptor Repair Kit with ENFit Connectors, Size on 3 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-2161-2017.
Why was it recalled?
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Which lots are affected?
Catalogue Numbers: 50-6112
Where was it sold?
Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CORPAK MedSystems
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Corflo, PEG Adaptor Repair Kit with ENFit Connectors, Size recalled | CORPAK MedSystems | Device Malfunction | CA, NH, VT |
| Device | CLASS II | Corflo PEG Kit, Pull recalled by CORPAK MedSystems | CORPAK MedSystems | Device Malfunction | CA, NH, VT |
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| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | Bd Switzerland Sarl | Other | IL |