Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
- Company
- Circulatory Technology Inc
- Recall Initiated
- March 3, 2016
- Terminated
- April 20, 2017
- Recall Number
- Z-2050-2016
- Quantity
- 72 units
- Firm Location
- Oyster Bay, NY
Reason for Recall
The seal between the balloon and the housing may leak.
Distribution
US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
Lot / Code Info
Lot # 014603 USE BY: 9/2018
Root Cause
Device Design
Action Taken
Circulatory Technology Inc. sent an Urgent Product Recall notices dated March 3, 2016, to their customers via email. Circulatory Technology Inc. has identified this action as a voluntary recall, however they did not withdraw the product from the market. Instead, Circulatory Technology Inc. has advised customers to check the integrity of the seal between both the inlet and outlet tube and the housing as per the Instructions For Use. In addition, for this lot, Circulatory Technology Inc. recommends that you bend the inlet as well as the outlet tube away from the housing before conducting the leak test. There should be no visible separation between the tubing and the housing. Customers with questions can call 516-624-2424.