Recall Z-1754-2018 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cook Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
| Date | May 9, 2018 (initiated Mar 29, 2018) |
| Status | Terminated |
| Reason | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube. |
| Root cause | Equipment maintenance |
| Action | On March 29, 2018, the recalling firm mailed recall notifications to affected customers. Customers were informed that the affected devices may have been manufactured with equipment that was out of calibration, which could result in the cap-adapter assembly of the device not being adequately tightened. Customers were advised of potential adverse events. Customers were instructed to 1) Examine inventory immediately to determine if they have affected product, and quarantine affected product. Immediately cease all distribution and use of the recalled lots. 2) Return the affected product to the re |
| Quantity | 304 |
| Distribution | Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.