Z-1578-2022 Class II Ongoing
FDA device recall Z-1578-2022 was initiated by Baxter Healthcare Corporation on Jul 22, 2022 and is designated Class II. Reason for recall: There is a potential of the packaging not maintaining a sterile barrier for the tip caps. The recall status is ongoing. Affected quantity: 24,320 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2022
- Initiation Date
- Jul 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,320 units
Product Description
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
Reason for Recall
There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
Distribution Pattern
Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.
Code Information
a) 25 pack REF H938693025, UDI 00085412479965, ALL LOTS; b) 100 pack REF H938673100, UDI 00085412479798, ALL LOTS
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1578-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026