Recall Z-0807-2021
Baxter Healthcare Corporation · initiated December 11, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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
Reason for recall
VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
FDA-determined cause: Process design
Action taken
An Urgent Medical Device Recall communication, FA-2020-057, will be sent to all affected customers via U.S.P.S., first class mail.
Details
- Recall number
- Z-0807-2021
- Initiated
- December 11, 2020
- Terminated
- March 24, 2023
- Product code
- FTM – Mesh, Surgical
- 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.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL