FDA Device Intelligence
HomeManus Medical, LLC › Manus Medical, LLC

Manus Medical, LLC

Manus Medical, LLC · Model H-CR-01 36A CUST SUP · UDI-DI 00811870037726

FRL Prescription
10
510(k) clearances
197
Adverse events (1 deaths)
6
Recalls
391
Facilities

Description

Econowipe 36A Cust Sup

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.