FDA-Device2016-08-31Class II
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.
Richard Wolf Medical Instruments Corp.
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.
Sold states
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.
Affected count
Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces
Manufactured in
353 Corporate Woods Pkwy, Vernon Hills, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2608-2016Don't want to check this manually?
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