Device product

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100

Z-1578-2022

July 22, 2022

Class II

Product summary

Firm: Baxter Healthcare Corporation
Event: Event 90658
Status: Ongoing
Classification: Class II
Quantity: 24,320 units
Official record key: device-enforcement:Z-1578-2022

Official wording

Reason: There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

Code information: a) 25 pack REF H938693025, UDI 00085412479965, ALL LOTS; b) 100 pack REF H938673100, UDI 00085412479798, ALL LOTS

Distribution pattern: Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

There is a potential of the packaging not maintaining a sterile barrier for the tip caps.