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VERITAS Collagen Matrix - Product Usage: intended for use… recallZ-0807-2021 · Baxter Healthcare Corporation · initiated Dec 11, 2020

Class II Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.

FDA root cause category: Process design

What the company is doing

An Urgent Medical Device Recall communication, FA-2020-057, will be sent to all affected customers via U.S.P.S., first class mail.

Recall details

Recall number
Z-0807-2021
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 11, 2020
Recalling firm
Baxter Healthcare Corporation
Quantity
192 units
Product code
FTM
FDA submissions
K062915
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.

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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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