Device product

Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D

Z-1735-2024

March 27, 2024

Class II

Product summary

Firm: Cardinal Health 200, LLC
Event: Event 94309
Status: Ongoing
Classification: Class II
Quantity: 202 cases of 12
Official record key: device-enforcement:Z-1735-2024

Official wording

Reason: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.

Code information: UDI/DI 50192253016411 (Case), 20192253016410 (Box), 10192253016413 (Each), Lot Numbers: 231251D1, 231151D1, 210751D1

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.