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Recall Observatory FDA recall evidence

Device product

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.

Z-2163-2017

February 03, 2017

Class II

Product summary

Firm
CORPAK MedSystems, Inc.
Event
Event 76465
Status
Terminated
Classification
Class II
Quantity
8 cases (2 units per case)
Official record key
device-enforcement:Z-2163-2017

Official wording

Reason: Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.

Code information: Catalogue Numbers: 50-6016

Distribution pattern: Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.