Z-1380-2024 Class II Ongoing
FDA device recall Z-1380-2024 was initiated by Baxter Healthcare Corporation on Feb 28, 2024 and is designated Class II. Reason for recall: A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for… The recall status is ongoing. Affected quantity: 4774 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2024
- Initiation Date
- Feb 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4774 units
Product Description
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
Reason for Recall
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
Distribution Pattern
US Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign) countries of: Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and United Kingdom.
Code Information
a) SPG0404, UDI/DI 00085412818672; b) SPG0406, UDI/DI 00085412818696; c) SPG0608, UDI/DI 00085412818313; d) SPG0814, UDI/DI 00085412818375; e) SPG1016, UDI/DI 00085412818429; ALL LOTS WITHIN EXPIRY
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1380-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026