Baxter Healthcare Corporation: 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

Is my product affected?

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.

• UPC 00085412531274

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling 192 units of VERITAS Collagen Matrix 12x25 cm Patches used for pelvic floor reconstruction. The patches may have undersized width dimensions, which could affect their proper fit and function during medical procedures. The affected product was distributed worldwide, including throughout the United States and in Australia, Poland, and the United Kingdom. The recalled patches are identified by Product Code RM1225BIO or RM1225, and the affected lot numbers span from July 2022 through August 2023.

Consumers and healthcare providers with affected VERITAS Collagen Matrix patches should consult the product recall record, as the source does not specify a remedy or recommended action.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions. 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. Quantity: 192 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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