Device product

BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2176-2026

April 10, 2026

Class II

Product summary

Firm: Stryker Sustainability Solutions
Event: Event 98708
Status: Ongoing
Classification: Class II
Quantity: 28 units
Official record key: device-enforcement:Z-2176-2026

Official wording

Reason: Incomplete seals on sterile product

Code information: UDI 00885825003135, Lot Numbers: 2268964, 2687510, 3173767, 3269330, 3379246, 4398753, 4876242, 2501717, 2878890, 3231930, 3336473, 3394078, 4780878, 4876243, 2533915, 3137651, 3266358, 3361335, 3454810, 4821709.

Distribution pattern: US Nationwide and the countries of Israel and Canada.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Incomplete seals on sterile product