Mozarc Medical US LLC: Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Hazard

Potential breach of sterile barrier packaging.

Details from the source

Reason for recall: Potential breach of sterile barrier packaging. Distribution: Worldwide distribution - US Nationwide and the countries of Canada & Mexico. Quantity: 95,938 units Lot/code info: Model No.8888133508P, 8888123408P, 8888119368P, 8888128458P; UDI: 20884521157931, 20884521157795, 20884521157726, 20884521157863; Serial No. 2234800132, 2302500141, 2302500148, 2305300142, 2305300144, 2305300177, 2313800083, 2324100168, 2324100310, 2324100311, 2405800229, 2426300218, 2426700122, 2427700199.

UPC codes

20884521157931, 20884521157795, 20884521157726, 20884521157863

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.