Recall Z-2608-2016— Richard Wolf Medical Instruments Corp.
Class II · Terminated
Class II FDA medical device recall by Richard Wolf Medical Instruments Corp., initiated 2016-05-19, terminated 2017-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.. Reason: The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients..
- Recalling firm
- Richard Wolf Medical Instruments Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-19
- Terminated
- 2017-11-30
- Firm location
- Vernon Hills, IL, United States
Product description
Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
Reason for recall
The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.
Data sourced from openFDA. This site is unofficial and independent of the FDA.