Z-1708-2018 Class II Terminated
FDA device recall Z-1708-2018 was initiated by Datascope Corporation on October 19, 2017 and is designated Class II. 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 balloo… The recall status is terminated (terminated April 24, 2020). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- October 19, 2017
- Termination Date
- April 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
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 Pattern
Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.
Code Information
Lot 3000057378, 3000061216