—#33672

Product

Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Manufactured by Sterion Incorporated, Ham Lake, MN for Argon Medical Devices, Athens, Texas.

FDA product code: KDC — Instrument, Surgical, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog Number: 001-1-110: Lot numbers.31005619, 040307981, 031105860, 040106663 Catalog Number: 001-1-320: Lot Numbers: 040308006, 040106665, 040307894, 031005622, 031105863, Catalog Number: 001-1-120: Lot Numbers: 040106664, 040307892, 040307982, Catalog Number: 001-1-140: Lot Number: 031065620 Catalog Number: 001-1-310: Lot Numbers: 031005621, 031105862, 040106667, 040307893, 040308005 Catalog Number: 001-1-330: Lot Numbers: 040106666, 040307895, 040308044

Why it was recalled

Inadequate closure compromising sterility.

Root cause (FDA determination)

Other

Action the firm took

The recall was initiated by certified letter on 06/22/2004.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

Distribution pattern: Distribution ocurred in the following states PA, MO, NJ, OH, CA, VA, NM, TX, NE, and to Tokyo, Japan.

Timeline

Recall initiated: 2004-06-22
Posted by FDA: 2004-07-20
Terminated: 2005-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.