FDA recall Z-1707-2018

Product

Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513

Reason for recall

The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.

Distribution

Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.

Key facts

Status

Terminated

Initiation date

2017-10-19

Report date

2018-05-16

Termination date

2020-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1707-2018