Conical portio adapter recall
Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological…
Why was Conical portio adapter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922
- Product
- Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological…
- Recalling firm
- Richard Wolf Medical Instruments Corp.
- 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.
- Recall date
- August 31, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)