Z-0424-2014Class II

20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is...

Name: Z-0424-2014 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is...
Creator: B. Braun Medical, Inc.
Published: 2013-04-04
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2013-04-04 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a 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 a Partial Additive... on 2013-04-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0424-2014
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Posted: 2013-11-27
Terminated: 2014-08-26
Recalling firm: B Braun Medical Inc
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.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: B Braun sent an Urgent - Medical Device Removal Notification letter dated April 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by he customer. Customers were instructed to review the Product Recall Notification in its entirety and ensure that all users in their organization are informed about this voluntary product recall. Determine their current inventory of the affected lots within their distribution center. Contact their customers that have received the affected lots and inform them of this voluntary product recall. Combine both their inventory, and the inventory reported by their customers, and utilize their specific "Product Removal Acknowledgement" form to record the total number of individual units (within partial cases) and the number of full-unopened cases. If no inventory remaining enter zero (0). Return the completed Acknowledgement Form to BBMI Quality Assurance in the self addressed envelope or fax to 610-849-1197. Customers should call Customer Support Department at 800-227-2862 to arrange for eturn and replacement product or for questions. For questions regarding this recall call 800-227-2862.
Quantity in commerce: 1,746,079 units
Distribution: Nationwide Distribution
Product codes and lots: Material BC2000, Lot numbers 0061275133, 0061275135, 0061275136, 0061279143, 0061279144, 0061279145, 0061279146, 0061289059, 0061289060, 0061289061, 0061289062, 0061289063, 0061289064, 0061289065, 0061289066, 0061289067 and 0061299664.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0424-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0424-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0425-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27

Product code LHI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)