Device product
20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
Z-0424-2014
Product summary
- Event
- Event 65356
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,746,079 units
- Official record key
device-enforcement:Z-0424-2014
Official wording
Reason: Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector, which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result i
Code information: Material BC2000, Lot numbers 0061275133, 0061275135, 0061275136, 0061279143, 0061279144, 0061279145, 0061279146, 0061289059, 0061289060, 0061289061, 0061289062, 0061289063, 0061289064, 0061289065, 0061289066, 0061289067 and 0061299664.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector, which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result i