251 units were distributed. Noncompliance with the performance standard for laser products in that the shutter may not close completely, and that the shutter monitor does not turn off the laser in this situation. Firm-initiated recall ongoing. Minnesota, South Carolina, Arkansas, Texas, Ohio, Belgium, France. 19 pieces were distributed.
Product is labeled with an incorrect color-coded sticker.
The codes of the sticker is correct for the device, but shows a likeness of a patella component. Vedco Lactated Ringer's Injection, in 1000 ml bottles. Firm- initiated recall ongoing. Major distributors are located in Virginia, Texas, South Dakota, Pennsylvania and Idaho. Product may have been distributed to surrounding states.