Cook Endoscopy 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Cook Endoscopy
Lot Codes / Batch Numbers
Lot number W2676476
Products Sold
Lot number W2676476
Cook Endoscopy is recalling Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscop due to The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026