BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
Reported: May 16, 2018 Initiated: October 19, 2017 #Z-1731-2018
Product Description
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
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.
Details
- Recalling Firm
- Datascope Corporation
- Units Affected
- 11
- Distribution
- Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.
- Location
- Fairfield, NJ
Frequently Asked Questions
What product was recalled? ▼
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874. Recalled by Datascope Corporation. Units affected: 11.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1731-2018.
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