Recall Z-1530-2024 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cook Incorporated
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6.0-38-15 5) JCD8.0-38-15 6) JCD8.0-38-20
| Date | Apr 12, 2024 (initiated Mar 1, 2024) |
| Status | Open, Classified |
| Reason | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| Root cause | Under Investigation by firm |
| Action | Cook Medical issued Urgent Medical Device Recall letter on 3/1/24 to Risk Management/Recall Administration. . Letter states reason for recall, health risk and action to take: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form |
| Quantity | 5,998 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183036 | Dilator Sets Cook Incorporated, Dec 20, 2018 |