Z-1380-2024Class II

Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e)...

Name: Z-1380-2024 Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e)...
Creator: Baxter Healthcare Corporation
Published: 2024-02-28
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-02-28 / Open, Classified / root cause: labeling and UDI

FDA source

Baxter Healthcare Corporation began a recall of Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016 on 2024-02-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1380-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-28
Posted: 2024-03-26
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
Product code: FTM Mesh, Surgical
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Baxter issued a "SAFETY ALERT" to its consignees on 02/28/2024 via USPS first class mail. the notice explained the problem, potential hazard involved with off-label use of the product and the actions to be taken. The firm requested that the notice be forwarded all affected facilities or departments with institutions. Distributors are directed to notify their customers. For questions, contact Baxter Healthcare Center for Service at 888-229-0001, between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Quantity in commerce: 4774 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1380-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1377-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-26
Z-1378-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-26
Z-1379-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-26
Z-1380-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-26

Product code FTM

K223052Class IIPeri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc. / cleared 2023-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)