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U.S. Department of Health and Human Services

Class 2 Device Recall SUPPLE PERIGUARD Repair Patch

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 Class 2 Device Recall SUPPLE PERIGUARD Repair Patchsee related information
Date Initiated by FirmFebruary 28, 2024
Date PostedMarch 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1378-2024
Recall Event ID 94152
510(K)NumberK983162 
Product Classification Mesh, surgical - Product Code FTM
ProductBaxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
Code Information a) PC0404SNBIO, UDI/DI 00085412530642; b) PC0608SNBIO, UDI/DI 00085412530673; c) PC0814SNBIO, UDI/DI 00085412530697; d) PC1016SNBIO, UDI/DI 00085412530710; ALL LOTS WITHIN EXPIRY
Recalling Firm/
Manufacturer
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2
Labeling Change Control
ActionBaxter 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 Commerce9549 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FTM
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