Jejunal Feeding Set, Product Order number FLOWJ-9-20 recallZ-1910-2009 · Cook Endoscopy · initiated Jul 24, 2009
Terminated All recalls posted in September 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook Endoscopy or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1910-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 24, 2009
- Posted by the FDA
- Sep 1, 2009
- Recalling firm
- Cook Endoscopy
- Quantity
- 4 units
- Product code
- KNT
- FDA submissions
- K920703
- Distribution
- International Only Distribution -- Country of Italy.
Product description
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.
Code information (models, lots, serial numbers)
Lot number W2676476
Other devices under the same FDA submission
7 devices cleared under K920703 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PEG 24 G22636Cook Incorporated · TUBES, GASTROINTESTINAL (AND ACCESSORIES)11 reports
- Flow 20 G22637Cook Incorporated · TUBES, GASTROINTESTINAL (AND ACCESSORIES)4 reports
- Flow 20 G22638Cook Incorporated · TUBES, GASTROINTESTINAL (AND ACCESSORIES)3 reports
- Flow 20 G22761Cook Incorporated · TUBES, GASTROINTESTINAL (AND ACCESSORIES)3 reports
- Flow 20 G56403Cook Incorporated · TUBES, GASTROINTESTINAL (AND ACCESSORIES)3 reports
- PEG 24 G22635Cook Incorporated · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death1 report
- Flow 20 G31543Cook Incorporated · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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