Recall record at a glance
| Official record | Z-2608-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Richard Wolf Medical Instruments Corp. |
| Report date | Aug 31, 2016 |
| Recall initiation date | May 19, 2016 |
| Quantity | Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces |
| Location | Vernon Hills, IL, United States |
Official 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.
Why the product 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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