Reported Jul 20, 2022 · Ongoing
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX,…
Cordis US Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cordis US Corp · 14201 Nw 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Product as published PG2990BPSLot numbers 82184806, exp. 12/31/2022 — 82191321, exp. 3/31/2023 PG2990BPXand 82208532, exp. 10/31/2023. - Lot numbers 82185924, exp. 1/31/2023 PG3990BPSand 82208528, exp. 10/31/2023. - Lot numbers 82180267, exp. 10/31/2022 — 82191527, exp. 3/31/2023 — 82193089, exp. 5/31/2023 PG3990BPXand 82206059, exp. 10/31/2023. - Lot numbers 82208524, exp. 11/30/2023 — and 82211296, exp. 12/31/2023. - Amount recalled
- 1,089 units
Where it was sold
Why it was recalled
Potential for stent dislodgement and associated failures related to two specific sizes of the device.
This product could cause temporary or reversible health problems — stop using it.
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