Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic placement to provi
FDA device recall Z-1910-2009 · posted 2009-09-01 · Terminated
Recall details
- Recalling firm
- Cook Endoscopy
- Reason for recall
- The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 4 units
- Distribution
- International Only Distribution -- Country of Italy.
- Date initiated
- 2009-07-24
- Date posted
- 2009-09-01
- Date terminated
- 2010-04-06
- Location
- Winston Salem, NC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GASTROINTESTINAL FEEDING TUBE (K920703) | Wilson-Cook Medical, Inc. | 1993-12-03 |