Olympus Corporation Recalls Resection Sheaths Due to Risk of Ceramic Tip Breakage
Olympus Corporation of the Americas is recalling 118 Resection Sheaths used in urologic procedures due to reports of the ceramic tip breaking.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of its Resection Sheath (28 Fr.) following complaints that the ceramic tip of the device can break. This recall was classified by the FDA as a Class II recall, indicating that the use of the product may cause temporary or medically reversible adverse health consequences.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: Olympus Resection Sheath, 28 Fr.
- Model Number: A22043A
- UDI: 04042761021005
- Affected Lots: All lots
- Quantity: 118 units
The affected units were distributed nationwide across the United States.
What You Should Do
Olympus Corporation of the Americas initiated the recall process by sending notification letters to affected customers. Healthcare facilities and providers should immediately check their inventory for Model No. A22043A. If you possess any units from the affected lots, you should follow the specific instructions provided in the firm’s notification letter regarding the handling and return of the devices.
Why This Matters
A broken ceramic tip during a urologic procedure poses a risk of injury to the patient or the introduction of foreign material into the body, which may necessitate additional medical procedures to resolve.
Source
Source: FDA Official Notice