PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
FDA Recall Z-1363-2022 · Posted None
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Recalling FirmCordis US Corp
Recall StatusOpen, Classified
Product CodeFGE
Date Initiated2022-05-20
Product Quantity1,089 units
Reason for Recall
Potential for stent dislodgement and associated failures related to two specific sizes of the device.
Firm 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.
Root Cause
Process design
Distribution Pattern
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.
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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