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U.S. Department of Health and Human Services

Class 2 Device Recall PALMAZ GENESIS

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 Class 2 Device Recall PALMAZ GENESISsee related information
Date Initiated by FirmMay 20, 2022
Create DateJuly 11, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1363-2022
Recall Event ID 90253
510(K)NumberK033394 
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
ProductPALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Code Information Catalog #PG2990BPS - Lot numbers 82184806, exp. 12/31/2022; 82191321, exp. 3/31/2023; and 82208532, exp. 10/31/2023. Catalog #PG2990BPX - Lot numbers 82185924, exp. 1/31/2023; and 82208528, exp. 10/31/2023. Catalog #PG3990BPS - Lot numbers 82180267, exp. 10/31/2022; 82191527, exp. 3/31/2023; 82193089, exp. 5/31/2023; and 82206059, exp. 10/31/2023. Catalog #PG3990BPX - Lot numbers 82208524, exp. 11/30/2023; and 82211296, exp. 12/31/2023.
Recalling Firm/
Manufacturer		 Cordis US Corp
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information ContactKaren Hackstaff
786-313-2000
Manufacturer Reason
for Recall		Potential for stent dislodgement and associated failures related to two specific sizes of the device.
FDA Determined
Cause 2		Process design
ActionThe 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 in Commerce1,089 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FGE
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