CORFLO PEG Kit, Pull 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.
FDA Recall Z-2163-2017 · Posted None
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Recalling FirmCORPAK MedSystems, Inc.
Recall StatusTerminated
Product CodeKNT
Date Initiated2017-02-03
Date Terminated2019-08-05
Product Quantity8 cases (2 units per case)
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.
Firm Action
Firm provided consignees with field correction on 2/2/2017 by letter mailed via FedEx. Within the notice, the firm provided additional instructions for handling the PEG Y-Adapter to help reduce the likelihood for exposing the stem to excess stress that could break the connector. Consignees were instructed to forward the field correction notice to all staff members or end-users who use the ENFit Y-Adapter.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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