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.
This recall has been terminated (originally issued September 1, 2009).
- Company
- Cook Endoscopy
- Recall Initiated
- July 24, 2009
- Posted
- September 1, 2009
- Terminated
- April 6, 2010
- Recall Number
- Z-1910-2009
- Quantity
- 4 units
- Firm Location
- Winston Salem, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
Distribution
International Only Distribution -- Country of Italy.
Lot / Code Info
Lot number W2676476
Root Cause
Process control
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.