| Class 2 Device Recall VERITAS Collagen Matrix | |
Date Initiated by Firm | December 11, 2020 |
Create Date | January 08, 2021 |
Recall Status1 |
Terminated 3 on March 24, 2023 |
Recall Number | Z-0807-2021 |
Recall Event ID |
86930 |
510(K)Number | K062915 |
Product Classification |
Mesh, surgical - Product Code FTM
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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. |
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 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625
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For Additional Information Contact | Center for One Baxter 800-422-9837 |
Manufacturer Reason for Recall | VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions. |
FDA Determined Cause 2 | Process design |
Action | An Urgent Medical Device Recall communication, FA-2020-057, will be sent to all affected customers via U.S.P.S., first class mail. |
Quantity in Commerce | 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. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FTM
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