Recall Z-1379-2024
Baxter Healthcare Corporation · initiated February 28, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
Codes / lots: a) PG0404, UDI/DI 00085412818405; b) PG0608, UDI/DI 00085412818443; c) PG0814, UDI/DI 00085412818597; d) PG1016, UDI/DI 00085412818610; e) PG1225, UDI/DI 00085412818658; ALL LOTS WITHIN EXPIRY
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: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-1379-2024
- Initiated
- February 28, 2024
- Posted by FDA
- March 26, 2024
- Product code
- FTM – Mesh, Surgical
- Quantity
- 2413 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.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1377-2024 Class II | Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c)…A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in… | 02/28/2024Open, Classified |
| Z-1378-2024 Class II | Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b)…A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in… | 02/28/2024Open, Classified |
| Z-1380-2024 Class II | Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c)…A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in… | 02/28/2024Open, Classified |