Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dua
Check against the official notice below — it lists the full affected range.
Medtronic is voluntarily recalling two production lots of Covidien Vistec x-ray detectable sponges due to possible contamination with human blood that occurred during manufacturing and handling before final packaging and sterilization. The affected lot numbers are 17E121362 and 17E121262, with a total of 33,280 units recalled. These sponges are medical absorbent devices used in medical procedures.
The recalled products were distributed in the United States, U.S. government accounts, and foreign countries including Pennsylvania, Puerto Rico, and Colorado. The recall record does not specify what actions affected consumers should take regarding this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.
Reason for recall: Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization. Distribution: U.S., Gov Accts, and foreign countries: PA, PR, CO. Quantity: 33,280 Lot/code info: Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.