FDA Device recall Z-0424-2014
20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between…
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between… by B Braun Medical, citing 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, i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0424-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-04 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | B Braun Medical |
| Distribution | US |
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.
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
Identifiers
| code_info | Material BC2000, Lot numbers 0061275133, 0061275135, 0061275136, 0061279143, 0061279144, 0061279145, 0061279146, 006128…Material BC2000, Lot numbers 0061275133, 0061275135, 0061275136, 0061279143, 0061279144, 0061279145, 0061279146, 0061289059, 0061289060, 0061289061, 0061289062, 0061289063, 0061289064, 0061289065, 0061289066, 0061289067 and 0061299664. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0424-2014%22
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