Device product
VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.
Z-3030-2017
Product summary
- Event
- Event 77696
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,546,800 units
- Official record key
device-enforcement:Z-3030-2017
Official wording
Reason: Punctures in blister packaging that was detected during the packaging process.
Code information: Lot No. 1470303001, 1570314802, 1470303002, 1570317701, 1470304601, 1570317702, 1470306602, 1570317703, 1470306301, 1570317704, 1470306602, 1570322001, 1470311301, 1660771501, 1470306301, 1470311302, 1470314801
Distribution pattern: Worldwide Distribution in the states of : CO, IL, IN, MD, MI, NY, OH, & TX. and foreign countries of: Australia, New Zealand, & Japan.
Derived failure modes
-
Unknown
Punctures in blister packaging that was detected during the packaging process.