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.
FDA Recall Z-1910-2009 · Posted 2009-09-01
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Recalling FirmCook Endoscopy
Recall StatusTerminated
Product CodeKNT
Date Initiated2009-07-24
Date Terminated2010-04-06
Product Quantity4 units
Reason for Recall
The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
Firm 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.
Root Cause
Process control
Distribution Pattern
International Only Distribution -- Country of Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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