FDA Device Intelligence
Home › AMSINO INTERNATIONAL, INC. › AMSure® Urinary Leg Bag with Extension Tube

AMSure® Urinary Leg Bag with Extension Tube

AMSINO INTERNATIONAL, INC. · Model 1 · UDI-DI 10704411006282

FAQ Prescription
10
510(k) clearances
399
Adverse events
7
Recalls
121
Facilities

Description

AMSure® Urinary Leg Bag with Extension Tube Large - 900 mL, Twist Valve

Recalls

DateFirmReason
2023-10-19MEDLINE INDUSTRIES, LP - NorthfieldUndeclared latex
2023-10-19MEDLINE INDUSTRIES, LP - NorthfieldUndeclared latex
2023-10-19MEDLINE INDUSTRIES, LP - NorthfieldUndeclared latex
2011-06-02Teleflex MedicalSterile integrity cannot be guaranteed.
2011-06-02Teleflex MedicalSterile integrity cannot be guaranteed.
2003-04-30Medegen Medical Products, LLCFinished products were not sterilized.
2003-03-25C.R. Bard, Inc., Urological DivisionThere is a potential for package seals to be open after sterilization.

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.