FDA Medical Device Recalls (openFDA)
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 number
- Z-1910-2009
- Recalling firm
- Cook Endoscopy
- 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.
- Status
- Terminated
- Initiated
- 2009-07-24
- Posted
- 2009-09-01
- Terminated
- 2010-04-06
- Reason
- The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
- 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
- 4 units
- Distribution
- International Only Distribution -- Country of Italy.
- Lot, serial or model codes
- Lot number W2676476
- 510(k) numbers
- K920703
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 1037905
- Firm city
- Winston Salem
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28