20mm addEASE — Class II medical device recall Z-0424-2014

Terminated recall by B. Braun Medical, Inc., reported 2013-12-04, distributed nationwide. Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC130

Recall number	`Z-0424-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	B. Braun Medical, Inc., Allentown, PA, United States
Recall initiated	2013-04-04
Classified	2013-11-27
Reported by FDA	2013-12-04
Terminated	2014-08-26
Distributed	Nationwide (US)
Quantity	1,746,079 units
Reason classes	packaging
Lot numbers	`0061275133`, `0061275135`, `0061275136`, `0061279143`, `0061279144`, `0061279145`, `0061279146`, `0061289059`, `0061289060`, `0061289061`, `0061289062`, `0061289063`, `0061289064`, `0061289065`, `0061289066`, `0061289067`, `0061299664`

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 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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0424-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.