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MEDTRONIC PS MEDICAL, INC. · Model 9025 · UDI-DI 00763000028190

FRL Prescription
1
510(k) clearances
281
Adverse events (1 deaths)
6
Recalls
392
Facilities

Description

CATH 9025 VENT STD XTRA LENGTH MARK IMP

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.