Recall Z-2608-2016 ยท HHI System, Abortion, Vacuum
Richard Wolf Medical Instruments Corp.
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.
| Date | May 19, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Customers impacted were notified via Urgent Medical Device Recall Letter dated 5/31/2016 via certified mail. The letter describes the reason for the recall. Richard Wolf Identified the following measures to be taken by the consignees: 1. Immediately examine your inventory and quarantine product subject to recall. Richard Wolf Medical Instruments Corporation strongly recommends not using the potentially defective products. Please make sure that all users of the aforementioned products become aware of this urgent safety information. 2. If you have further distributed this product, please id |
| Quantity | Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.