Laparoscopy Instruments Instructions For Use recall
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular…
Why was Laparoscopy Instruments Instructions For Use recalled?
The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.
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?
none
- Product
- Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular…
- Recalling firm
- Dannoritzer Medizintechnik GmbH & Co. KG
- Distribution
- US Nationwide in the States of OH, MI, MA, CA, OK, TN, GA, FL, IL, NC, TX, MO.
- Recall date
- October 10, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)