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Baxter Healthcare Corporation Recall 86930

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.

Baxter Healthcare Corporation Recall 86930 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0807-2021
Event ID86930
Event DescriptionVERITAS 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.
Product TypeDevices
DistributionWorldwide 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.
Quantity192 units
Recall ReasonVERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
Device Classification20210120
Device Code InfoProduct 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
Center Classification Date20210108
Recall Initiation Date20201211
Recalling FirmBaxter Healthcare Corporation
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