Device product
A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids.
Z-1271-2013
Product summary
- Event
- Event 64696
- Status
- Terminated
- Classification
- Class II
- Quantity
- A) Product Code 2N8371: 513,000 units
- Official record key
device-enforcement:Z-1271-2013
Official wording
Reason: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Code information: A) Product Code 2N8371: Lots R12E03108, R12H27085, R12H28075, R12H29057, R12H30139, R12103092, R12104058, R12105022, R12106061, R12110113, R12119056, R12120112, R12121151, R12122050, R12124106, R12124130, R12J25045, R12K03057, R12K19046, R12K21034, R12K21083, R12L05118, R12L08054, R12L18111, R12Ll9101, R13A08063, R13A08147, Rl3A09137, R13A10101, R13A14129, R13A15050
Distribution pattern: Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Derived failure modes
-
Unknown
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.