Recall Z-1363-2022 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cordis US Corp
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
| Date | May 20, 2022 |
| Status | Open, Classified |
| Reason | Potential for stent dislodgement and associated failures related to two specific sizes of the device. |
| Root cause | Process design |
| Action | The recalling firm issued letters dated 5/16/2022 on 5/20/2022 via FedEx to the U.S. customers. The letter explained the issue, provided details on the affected device to assist in the identification of the product involved, and requested the consignee immediately check their inventory for the affected product and quarantine it. An Acknowledgment Form was enclosed for completion and return to the recalling firm. The consignee was to share the letter with others in their facility who need to be made aware of the recall and with any other facility that may have been sent the affected units. |
| Quantity | 1,089 units |
| Distribution | US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY. There was also government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033394 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM Cordis Corp., Dec 22, 2003 |