Z-1575-2022 Class II Ongoing
FDA device recall Z-1575-2022 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: 602340 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2022
- Initiation Date
- Jul 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 602340 units
Product Description
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H938690025
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) REF H93866025, UDI 00085412478845, ALL LOTS; b) REF H93866100, UDI 00085412478852, ALL LOTS; c) REF H938690025, UDI 00085412479941, 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-1575-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026