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All product recalls associated with Cook Endoscopy.
Total Recalls
11
Past Year
0
Class I (Serious)
0
Most Recent
Jul 2009
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
The wire control port of these devices may be missing due to omission of a manufacturing activity.
The snare head is hexagonal but the handle and packaging indicate an oval reorder number.
The wire control port may have been omitted during manufacture.
A section of the introduction system may detach after the stent has deployed.
It is possible the stents inside CLSO-10-10, lot W2512492 were 5cm in length, instead of 10cm in length as listed on the product packaging label.
The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.
The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.
Large product label contains an incorrect expiration date.
The dilator size does not match the label on the product and product packaging.