Recall Z-3212-2018 ยท HBO Clip, Scalp
Medtronic Neurosurgery
Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use
| Date | May 3, 2018 |
| Status | Terminated |
| Reason | The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye. |
| Root cause | Under Investigation by firm |
| Action | Consignee Notification URGENT: MEDICAL DEVICE RECALL has been sent to US customers on 03-May-2018. For foreign customers, the Consignee Notification is in process. The Consignee letter informs customers of the situation and the required course of action which includes: 1. Cease use of the listed product 2. Account for number of product units used or discarded and return any units by completing the attached individualized Customer Confirmation form provided. Please follow the instructions described in the Customer Confirmation form. 3. Clinicians and their Patients who may have received the l |
| Quantity | 2616 |
| Distribution | Domestic: AL, AZ, AR, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, LA, MD, MI, MN, MS, MO, NB, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY OUS: Australia, Germany, Kenya, Russian Federation, South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050044 | MEDTRONIC CLIP GUN KIT Medtronic Neurosurgery, Feb 7, 2005 |