Device product
AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
Z-0813-2014
Product summary
- Event
- Event 67255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3850
- Official record key
device-enforcement:Z-0813-2014
Official wording
Reason: Defective component may cause extension sets to leak.
Code information: Lot Number: 1306034, 1307011
Distribution pattern: US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, OH
Derived failure modes
-
Unknown
Defective component may cause extension sets to leak.