Ligamax 5 mm Endoscopic Multiple Clip Applier

A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.

On November 7, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT: MEDICAL DEVICE RECALL (REMOVAL) LIGAMAX 5mm Endoscopic Multiple Clip Applier Product Codes: EL5ML (Multiple Lot Numbers) Dear Valued Customer Ethicon has initiated a voluntary medical device recall (removal) of specific lots of LIGAMAX 5mm Endoscopic Multiple Clip Applier. Ethicon identified that a potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility. In the event that the sterility barrier has been breached, there is a chance that a pathogen may be introduced and if unrecognized or untreated may cause life threatening infection. As the population at risk is most likely to receive prophylactic antibiotics the probability of harm is extremely rare. We have identified the root cause and have implemented corrective actions to address the issue and prevent reoccurrence. As of the date of this communication, no adverse events or complaints have been reported for this issue. Our records indicate that you may have ordered or received product subject to this recall. PLEASE DISTRIBUTE THIS INFORMATION TO ALL STAFF WITHIN YOUR FACILITY WHO USE LIGAMAX 5mm ENDOSCOPIC MULTIPLE CLIP APPLIER. The dates of distribution for affected products were from July 31, 2019 thru October 4, 2019. EFFECTIVE IMMEDIATELY DO NOT USE OR DISTRIBUTE THE FOLLOWING PRODUCT CODE/ LOT: Product Name: LIGAMAX Product Code: EL5ML Product Lots: T93X4R, T93X9D, T93Y2Z, T93Y70, T93Y96, T93Z52, T93Z76, T9401C, T9408F T94118, T9416M, T9422K, T9426Z, T94402, T94536, T94567, T9461M, T94667, T94721, T94758, T94807, T9484Y, T9487J, T9491A, T94A9K, T94C2Z, T94C8N, T94D2N, T94E66, T94F3C, T94F7F, T94G99, T94H1N T94H78 Description/Size: 5mm Endoscopic Multiple Clip Applier Note: This recall is specific to lots described. Health care practitioners who have treated pat