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Terminated

Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

FDA Recall Z-2050-2016 · Posted None

Recalling FirmCirculatory Technology Inc
Recall StatusTerminated
Product CodeDTN
Date Initiated2016-03-03
Date Terminated2017-04-20
Product Quantity72 units

Reason for Recall

The seal between the balloon and the housing may leak.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981284BETTER-BLADDER (BB)Circulatory Technology, Inc. · 1998-08-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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