Agency classClass IIOur severity:Moderate FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: dimensional-defect
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:

Same manufacturer · Baxter Healthcare Corporation

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