Richard Wolf Medical Instruments Corp. recalls Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic acce…

Recall date

May 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2608-2016

FDA classification

Class II

Brand / firm

Richard Wolf Medical Instruments Corp.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.