FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BARD Dynamic XT Steerable electrophysiology catheter recalled for incomplete sterile seals
Nationwide distributiondevice
Stryker BARD Dynamic XT catheter recalled for incomplete sterile seals
Stryker Sustainability Solutions is recalling the BARD Dynamic XT Steerable electrophysiology catheter (Product Number 201103) due to incomplete seals on the sterile packaging. This defect could compromise the sterility of the device. The recall affects specific lot numbers distributed nationwide in the US, as well as in Israel and Canada.
- If you have this catheter, stop using it and contact Stryker immediately.
- Do not use any units from the affected lot numbers.
- Return the device to Stryker or your supplier for replacement or instructions.
Hazard
Incomplete seals on sterile product
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide and the countries of Israel and Canada.
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2179-2026Don't want to check this manually?
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