CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM recalled

Cook is recalling Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM, distributed nationwide in the US. The recall was initiated on 29 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots NS7835000, NS7835001, NS7846433, NS7853877, NS7853880, NS7866660, NS7875342, NS7898129, NS7898130, NS7898131, NS7928009, NS7928014, NS7940349

Quantity recalled554

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1755-2018
FDA event ID: 79789
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 29 Mar 2018
FDA classified: 8 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

29 Mar 2018	Recall initiated by company
8 May 2018	Classified by FDA	+40 days
16 May 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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 catheter, arterial pressure monitoring, and fluid infusion.

Where it was distributed

Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.

Nationwide Alabama California Georgia Nebraska Nevada New York Texas

Stores named: Walmart

Questions about this recall

Is Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM recalled?

Yes. Cook recalled Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM on 29 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1755-2018.

Why was it recalled?

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.

Which lots are affected?

Lots NS7835000, NS7835001, NS7846433, NS7853877, NS7853880, NS7866660, NS7875342, NS7898129, NS7898130, NS7898131, NS7928009, NS7928014, NS7940349

Where was it sold?

Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Cook

All 264

Reported	Class	Recall	Company	Reason	Where
29 Dec 2021Device	CLASS II	Skinny Needle with Chiba Tip recalled by Cook	Cook	Other	Nationwide
22 Dec 2021Device	CLASS II	Flexor Check-Flo Introducer Ansel Modification recalled by Cook	Cook	Labeling Errors	14 states
22 Dec 2021Device	CLASS II	Flexor Check-Flo Introducer Ansel Modification recalled by Cook	Cook	Labeling Errors	14 states
24 Nov 2021Device	CLASS II	Transseptal Needle, Trocar recalled by Cook	Cook	Device Malfunction	Nationwide
24 Nov 2021Device	CLASS II	Transseptal Needle with Catheter recalled by Cook	Cook	Foreign Material	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide