Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a
Check against the official notice below — it lists the full affected range.
Stryker Sustainability Solutions recalled 90 reprocessed trocar sleeves from lot number 3574704 due to a labeling error. The devices were labeled as 100mm models (CB5LT) but actually contained 75mm models (CB5ST). The affected devices were distributed nationwide to Nevada, New Mexico, Texas, and Michigan.
The source record does not specify a remedy for consumers who may have received affected devices.
Written by software from the official notice below. Not reviewed by a lawyer.
Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST).
Reason for recall: Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST). Distribution: U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI. Quantity: 90 devices Lot/code info: Lot number 3574704 UDI Code: (01)00885825014421(17)180310(10)3574704 Model Number: CB5ST (labeled as CB5LT)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.