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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79789

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 29, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cook Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

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 catheter, arterial pressure monitoring, and fluid infusion.

Z-1751-2018
Recall number
Z-1751-2018
Initiated
March 29, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
220

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

lots 7853883 7871665 7940332

Distribution pattern

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

device · product 2 of 6

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 catheter, arterial pressure monitoring, and fluid infusion.

Z-1752-2018
Recall number
Z-1752-2018
Initiated
March 29, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
220

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

NS7881928, NS7898133

Distribution pattern

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

device · product 3 of 6

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 catheter, arterial pressure monitoring, and fluid infusion.

Z-1753-2018
Recall number
Z-1753-2018
Initiated
March 29, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
886

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lots 7828771, 7846437, 7863752, 7881930, 7886974, 7886975

Distribution pattern

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

device · product 4 of 6

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.

Z-1754-2018
Recall number
Z-1754-2018
Initiated
March 29, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
304

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lots 7844043, 7898128, 7940347, NS7904210

Distribution pattern

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

device · product 5 of 6

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.

Z-1755-2018
Recall number
Z-1755-2018
Initiated
March 29, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
554

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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

device · product 6 of 6

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 catheter, arterial pressure monitoring, and fluid infusion.

Z-1756-2018
Recall number
Z-1756-2018
Initiated
March 29, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
6345

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lots 7797164, 7844038, 7844039, 7844040, 7844041, 7844042, 7846434, 7846435, 7853869, 7853870, 7853871, 7853872, 7853873, 7853874, 7857491, 7857492, 7857493, 7857494, 7857495, 7857496, 7857497, 7857498, 7857499, 7857500, 7863742, 7863744, 7863745, 7863747, 7863748, 7863749, 7863750, 7863751, 7871644, 7871645, 7871646, 7871647, 7881937, 7881938, 7881939, 7881940, 7881941, 7881942, 7888498, 7888505, 7888506, 7888507, 7917423, 7917424, 7917425, 7917426, 7917434, 7925136, 7925137, 7925138, 7925139, 7925140, 7940326, 7940327, 7940328, 7940345, 7940346, 7949048, NS7835002, NS7875343, NS7881929, NS7888468, NS7928016, NS7940350

Distribution pattern

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