Z-3212-2018Class II

Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing...

Name: Z-3212-2018 Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing...
Creator: Medtronic Neurosurgery
Published: 2018-05-03
License: https://open.fda.gov/license/

Medtronic Neurosurgery / initiated 2018-05-03 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Neurosurgery began a recall of Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF... on 2018-05-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3212-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-03
Posted: 2018-09-21
Terminated: 2022-08-30
Recalling firm: Medtronic Neurosurgery
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
Product code: HBO Clip, Scalp
Reason for recall: 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 tag: labeling and UDI
FDA 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 listed devices should monitor the patients condition to determine if there are any signs of infection. If this is the case, the patient should seek medical attention immediately to treat the infection. In addition, the Notification Letter should be provided to all those who need to be aware of this matter within your organization or to any organization where the potentially affected products may have been transferred. Fax the Customer Acknowledgement Response Form to Medtronic Neurosurgery at (805) 571-8787 or take a clear picture or scan of signed form and email it to [email protected] with "Magazine Recall" in the subject line.
Quantity in commerce: 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
Product codes and lots: Product Number/CFN: CM8902 UDI-Device Identifier (GTIN/UPN): 20643169647200 Lot Numbers: 54984; 57188; 59558; 66312; and 67988

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3212-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3212-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21

Product code HBO

K050044Class IIMedtronic Clip Gun KitMedtronic Neurosurgery / cleared 2005-02-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)