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SOFSORB OR TOWEL

STANDARD TEXTILE CO., INC. · Model 49133K52 · UDI-DI 00634916006261

FRL
10
510(k) clearances
209
Adverse events (1 deaths)
6
Recalls
391
Facilities

Description

OR TOWEL SOFSORB O/DYE 16X26 KAUM RM (98 5222) USE: 49111152

Recalls

DateFirmReason
2021-05-25Medline Industries IncPotential for mold contamination (Aspergillus vadensis)
2017-12-11Medical Action Industries IncProduct sterility potentially compromised.
2016-03-31American Surgical CompanyProduct packaging defective compromising sterility
2016-03-31American Surgical CompanyProduct packaging defective compromising sterility
2009-07-21Coloplast Corp Skin Care DivColoplast determined that a portion of one lot of InterDry" Ag Lot number 1789435, did not meet the product specification for silver content. In this portion of the lot antimicrob
2006-02-093M Company / Medical DivisionAfter reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as sterile product.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.