Reported Aug 31, 2016 · Terminated
Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic…
Richard Wolf Medical Instruments Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Richard Wolf Medical Instruments Corp. · 353 Corporate Woods Pkwy · Vernon Hills, IL · 60061-3110
Is this the product you have?
- 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.
- Lot codes and dates
- Product number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922
- Amount recalled
- Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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