Recall Z-2162-2017— CORPAK MedSystems, Inc.
Class II · Terminated
Class II FDA medical device recall by CORPAK MedSystems, Inc., initiated 2017-02-03, terminated 2019-08-05. It names one FDA 510(k) clearance: K882867. Product: CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; 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.. Reason: Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress..
- Recalling firm
- CORPAK MedSystems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-03
- Terminated
- 2019-08-05
- Firm location
- Buffalo Grove, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.