Home / Recalls / Medical Devices
Richard Wolf Medical Instruments Corp. recalls Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic acces
Recalled August 31, 2016 · FDA recall Z-2608-2016 · Richard Wolf Medical Instruments
Hazard
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. · FDA Class II
Units
Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces
Sold at
U.S. Consignees: AK, AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, TX, UT and VA.
Description
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.
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.
Manufacturer(s)
Richard Wolf Medical Instruments Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →