Device product
BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
Z-2055-2018
Product summary
- Event
- Event 79709
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,568,900 total products
- Official record key
device-enforcement:Z-2055-2018
Official wording
Reason: Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
Code information: 1) UDI DI (01)50382903679831 PI (17)180531(10)7135828(30)1000 Lot/Serial # 7315828 Exp Date 5/31/2018 2) UDI DI (01)50382903679831 PI (17)180531(10)7146901(30)1000 Lot/Serial # 7125692 Exp Date 4/30/2018
Distribution pattern: US Nationwide, Argentina, Belize , Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, Taiwan
Derived failure modes
-
Unknown
Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube