Z-1910-2009

Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic...

Name: Z-1910-2009 Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic...
Creator: Cook Endoscopy
Published: 2009-07-24
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2009-07-24 / Terminated / root cause: manufacturing process

FDA source

Cook Endoscopy began a recall of Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients... on 2009-07-24. The reason FDA records is "The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1910-2009
Status: Terminated
Initiated: 2009-07-24
Posted: 2009-09-01
Terminated: 2010-04-06
Recalling firm: Wilson-Cook Medical Inc.
Product: Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional support.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The consignee was notified by an Urgent: Field Safety Notice, dated 07/24/2009. The distributor (Cook Ireland) was instructed to contact the Italian Company Representative. The appropriate Patient Care Manual with the Italian translation was provided to the medical facility with the assistance of the Area Representative. The Area Representative instructed the medical facility staff to provide the translated Patient Care Manual to the caregiver(s) of the patient that received the Jejunal Feeding Sets. The distributor is already aware of the situation. The lower portion of the letter was to be filled out and sent to Cook Endoscopy.
Quantity in commerce: 4 units
Distribution: International Only Distribution -- Country of Italy.
Product codes and lots: Lot number W2676476

Product code KNT

K920703Class IIGastrointestinal Feeding TubeWilson-Cook Medical, Inc. / cleared 1993-12-03

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)