The Recall Desk
ModerateFDA (Devices)·Z-0807-2021·Announced 2021-01-20

Baxter Recalls VERITAS Collagen Matrix Patches Due to Undersized Width

Baxter Healthcare is recalling 192 units of VERITAS Collagen Matrix patches because they may have undersized width dimensions. The recall covers US and international distribution.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a dimensional defect (undersized width) which is a quality issue rather than a direct biological or chemical hazard, fitting the Moderate category for low-risk contamination or minor defects without reported injuries.

Plain-English summary

Baxter Healthcare Corporation is recalling 192 units of VERITAS Collagen Matrix 12x25 cm patches. The product is intended for use in the reconstruction of the pelvic floor, excluding transvaginal pelvic organ prolapse, and for the repair of rectal prolapse, excluding rectocele.

The recall was initiated because the patches may have undersized width dimensions. The affected lots were distributed worldwide, including in the United States and in Australia, Poland, and the United Kingdom.

Healthcare providers and patients should stop using the affected product and contact Baxter Healthcare Corporation for further instructions or a replacement.

The recalled product

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.
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Surgical Mesh / Collagen Matrix
Hazard
Affected units
192

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Related recalls

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · dimensional defect

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