FDAClass IIOctober 12, 2016

CUSA Dissectron Fingertip Laparoscopic Cannula recall

CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes

Why was CUSA Dissectron Fingertip Laparoscopic Cannula recalled?

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

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?

Catalog Number F75221, Lot #0195486 with expiry 04/2021

Product
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
Recalling firm
Integra LifeSciences Corp.
Quantity
9
Distribution
Nationwide Distribution to KS only
Recall date
October 12, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls