Medtronic Clip Gun Magazines are recall: Sterility Concern
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
Why was Medtronic Clip Gun Magazines are recalled?
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.
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/CFN: CM8902 UDI-Device Identifier (GTIN/UPN): 20643169647200 Lot Numbers: 54984; 57188; 59558; 66312; and 67988
- Product
- 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
- Recalling firm
- Medtronic Neurosurgery
- 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
- Recall date
- October 3, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)