Recall Z-1910-2009 ยท KNT Tubes, Gastrointestinal (And Accessories)
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.
| Date | Sep 1, 2009 (initiated Jul 24, 2009) |
| Status | Terminated |
| 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 |
| Quantity | 4 units |
| Distribution | International Only Distribution -- Country of Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920703 | GASTROINTESTINAL FEEDING TUBE Wilson-Cook Medical, Inc., Dec 3, 1993 |