Food, drugs, devices › Cook Inc.
Device recall: Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a condu
FDA enforcement event 79789 is a device recall by Cook Inc. of Bloomington, IN, initiated 29 Mar 2018 and classified Class II, with 6 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 9 Apr 2019. Initiation: voluntary: firm initiated. Cook Inc. has 61 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cook Inc., Bloomington, IN.
Reason for recall
"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."
Distribution
"Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1751-2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-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… | 220 | Class II | Terminated | 16 May 2018 |
| Z-1752-2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS 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… | 220 | Class II | Terminated | 16 May 2018 |
| Z-1753-2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-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… | 886 | Class II | Terminated | 16 May 2018 |
| Z-1754-2018 | 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… | 304 | Class II | Terminated | 16 May 2018 |
| Z-1755-2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-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… | 554 | Class II | Terminated | 16 May 2018 |
| Z-1756-2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-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… | 6345 | Class II | Terminated | 16 May 2018 |
Context
Other enforcement events for Cook Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Apr 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.