| Class 2 Device Recall PERIGUARD Repair Patch | |
Date Initiated by Firm | February 28, 2024 |
Date Posted | March 26, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1377-2024 |
Recall Event ID |
94152 |
510(K)Number | K983162 |
Product Classification |
Mesh, surgical - Product Code FTM
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Product | Baxter Peri-Guard Repair Patch (legacy product codes):
a) PC0404NBIO,
b) PC0608NBIO,
c) PC0814NBIO,
d) PC1016NBIO |
Code Information |
a) PC0404NBIO, UDI/DI 00085412530529;
b) PC0608NBIO, UDI/DI 00085412530567;
c) PC0814NBIO, UDI/DI 00085412530581;
d) PC1016NBIO, UDI/DI 00085412530604;
ALL LOTS WITHIN EXPIRY |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625
|
For Additional Information Contact | Center 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 |
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 | 9899 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. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FTM
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