Z-1080-2012

CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding...

Name: Z-1080-2012 CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding...
Creator: Corpak Med Systems
Published: 2012-01-26
License: https://open.fda.gov/license/

Halyard Health / initiated 2012-01-26 / Terminated / root cause: packaging

FDA source

Corpak Med Systems began a recall of CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36" (91 cm), 3 Gram weighted bolus... on 2012-01-26. The reason FDA records is "The wrong size Twoomey adapter was packaged with the Jejunal tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1080-2012
Status: Terminated
Initiated: 2012-01-26
Posted: 2012-02-22
Terminated: 2012-03-21
Recalling firm: Halyard Health
Product: CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36" (91 cm), 3 Gram weighted bolus; individually packaged, 5 tubes per case; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #30-7361; For delivery of enteral nutrition Product Usage: For delivery of enteral nutrition
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: The wrong size Twoomey adapter was packaged with the Jejunal tube.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: Corpak MedSystems telephoned customers on January 26, 2012 and sent a follow-up Recall Notification letter dated January 27, 2012 via e-mail reiterating the telephone conversations. Customers were informed of the urgent product recall, the problem and the actions to be taken. Customers were instructed to inspect inventory, segregate any affected product and contact Corpak at 1-800-323-6305 to arrange for the return and replacement of the units found. Customers were advised to complete and return the enclosed acknowledgment form, indicating the number of affected units found in their inventory. Distributors were requested to notify their customers. For questions contact Corpak MedSytems at 1-800-403-3400.
Quantity in commerce: 145 units
Distribution: Worldwide Distribution - USA (nationwide) including the states of Georgia, Indiana, Kentucky, Maryland, Michigan, Minnesota, Tennessee, Utah and the countries of to Sweden and New Zealand.
Product codes and lots: catalog/reorder #30-7361, lot 46121, expiration: 2016-10

Product code KNT

K821906Class IICorpak Enteric Feeding Tube W/guide TipCorpak Medsystems / cleared 1982-07-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)