FDA Device Entity Profile: ASO LLC

Known Identifiers & Locations

FEI Numbers 1038758, 3005386949, 3005761322, 3025145822

Owner Operator Numbers 1038758

Locations Covered JUAREZ Chihuahua, MX; LAPU-LAPU CITY Cebu, PH; Palmetto, FL, US; SARASOTA, FL, US

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1038758	ASO LLC	SARASOTA, FL, US	Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device	View Details
3005761322	ASO AMERICAS, S. de R. L. de C. V.	JUAREZ Chihuahua, MX	Repack or Relabel Medical Device	View Details
3025145822	ASO LLC	Palmetto, FL, US	Repack or Relabel Medical Device	View Details
9681195	ASO PHILIPPINES, INC.	LAPU-LAPU CITY Cebu, PH	Export Device to the United States But Perform No Other Operation on Device,Repack or Relabel Medical Device,Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0004-2014	SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns. Reason: No antibacterial bandages were packed in boxes labeled as antibacterial.	2013-08-21	Terminated	View Details

Profile Disclaimer

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