Device product
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Z-2047-2017
Product summary
- Event
- Event 77049
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 units
- Official record key
device-enforcement:Z-2047-2017
Official wording
Reason: Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.
Code information: Lot number 0521148W, Exp. 10/21/2021
Distribution pattern: US Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.
Derived failure modes
-
Unknown
Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.