FDA Device

Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

Hazard

The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.

What You Should Do

Remedy

On 10/24/2019, Medtronic sent a "URGENT: MEDICAL DEVICE RECALL" notification to consignees via FedEx. The customer notification letter as consignees to do the following: 1. Identify, segregate, and quarantine affected products within your inventory 2. Complete the Customer Confirmation Form. Return the form to Medtronic via email at RS.NavFCA@Medtronic.com or via fax at 651-367-7075 within 30 days of receipt. 3. Contact Medtronic at 1-888-826-5603 to receive a return materials authorization (RMA) and schedule replacement product. Return affected products to: 4. Medtronic Product Services, Attention: RMA #, 1480 Arthur Ave Louisville, CO 80027 5. If you have questions E-mail Medtronic at RS.NavTechSupport@Medtronic.com or call 1-888-826-5603.

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Products

Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Brand
Medtronic Navigation, Inc.
UPC
Lot Numbers: 66503918A 066513519A 066529218A 066535518A 66503919 066513519C 66531018 066512319A 066513519E 066531018A 066512319C 66529218 66535518

Units Affected

10,448 disposable biopsy needles

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