VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor e...
FDA Recall #Z-0807-2021 — Class II — December 11, 2020
Product Description
VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.
Reason for Recall
VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
192 units
Distribution
Worldwide distribution - US Nationwide distribution including in the states of FL, IL, MA, MS, OH, OR, TX, VA, WA, WV and the countries of Australia, Poland, and United Kingdom.
Code Information
Product Code: RM1225BIO, RM1225; GTIN: 00085412531274; Lot Number/Expiration Date: SP20A15-1421512/ 10/8/2022, SP20F22-1459746/ 4/1/2023. SP20I03-1474281/ 6/30/2023, SP19K25-1412935/ 7/1/2022, SP19K25-1412937/ 7/1/2022, SP19L09-1415842/ 10/8/2022, SP20A16-1421898/ 10/8/2022, SP20B18-1429818/ 1/2/2023, SP20B20-1430375/ 1/2/2023, SP20C27-1439804/ 2/11/2023, SP20C27-1439818/ 2/11/2023, SP20D01-1440793/ 2/25/2023, SP20D28-1447333/ 2/25/2023, SP20E28-1454035/ 4/1/2023, SP20G08-1462458/ 4/30/2023, SP20G14-1463550/ 4/30/2023, SP20G14-1463605/ 4/30/2023, SP20G21-1465131/ 6/2/2023, SP20G14-1463552/ 6/2/2023, SP20I08-1474874/ 6/30/2023, SP20I08-1474885/ 8/5/2023, SP20I08-1474895/ 8/5/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated