Device product

MiniCap Extended Life PD Transfer Set

Z-0768-2021

November 10, 2020

Class II

Product summary

Firm: Baxter Healthcare Corporation
Event: Event 86883
Status: Terminated
Classification: Class II
Quantity: 72,771 units
Official record key: device-enforcement:Z-0768-2021

Official wording

Reason: Potential for no-flow and leaks under the twist clamp.

Code information: Product Code: 5C4482, UDI: 00085412007731, Lot#, Expiration Date: H20D13100, 4/13/2025; H20D27084, 4/27/2025; H20D30070, 4/30/2025; H20E13107, 5/13/2025; H20E19054, 5/19/2025; H20E22082, 5/22/2025; H20F09061, 6/9/2025; H20F15050, 6/15/2025; H20F18070, 6/18/2025; H20F24086, 6/24/2025; H20F29051, 6/29/2025; H20G13046, 7/13/2025; H20G27087, 7/27/2025; H20G30065, 7/30/2025; H20H05057, 8/5/2025; H20H14067, 8/14/2025; H20H19066, 8/19/2025

Distribution pattern: Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential for no-flow and leaks under the twist clamp.