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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80288

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

Open FDA event record

Event summary

Timeline bucket
June 11, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cardinal Health 200, LLC

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

11 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 11

Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Z-2485-2018
Recall number
Z-2485-2018
Initiated
June 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The suction valve may not close properly which could cause continuous suction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The suction valve may not close properly which could cause continuous suction.

Code information

Lot numbers 41717 and 71734.

Distribution pattern

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

device · product 2 of 11

Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Z-2486-2018
Recall number
Z-2486-2018
Initiated
June 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The suction valve may not close properly which could cause continuous suction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The suction valve may not close properly which could cause continuous suction.

Code information

Lot numbers 41742,41739,41740, and 41741.

Distribution pattern

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

device · product 3 of 11

Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Z-2487-2018
Recall number
Z-2487-2018
Initiated
June 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The suction valve may not close properly which could cause continuous suction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The suction valve may not close properly which could cause continuous suction.

Code information

Lot numbers 11742, 41742, 41746, 41752, 41751, 41761, 41762, 41753, 41763, 41765, 41754, 41756, 41759, 41755, 41757, and 41758.

Distribution pattern

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

device · product 4 of 11

Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Z-2488-2018
Recall number
Z-2488-2018
Initiated
June 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The suction valve may not close properly which could cause continuous suction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The suction valve may not close properly which could cause continuous suction.

Code information

Lot numbers 41718,41770,41768,41769,81702, and 81708.

Distribution pattern

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

device · product 5 of 11

Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Z-2489-2018
Recall number
Z-2489-2018
Initiated
June 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The suction valve may not close properly which could cause continuous suction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The suction valve may not close properly which could cause continuous suction.

Code information

Lot numbers 11740,41771,41772,41773, and 81709.

Distribution pattern

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

device · product 6 of 11

Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Z-2490-2018
Recall number
Z-2490-2018
Initiated
June 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The suction valve may not close properly which could cause continuous suction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The suction valve may not close properly which could cause continuous suction.

Code information

Lot numbers 21706, 21707, 31751, 31748, 31750, 31753, 41719, 41720, 61717, 61718, 61719, 71736, 71737, 91702, 91705, 91706, and 91721.

Distribution pattern

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

device · product 7 of 11

Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Z-2491-2018
Recall number
Z-2491-2018
Initiated
June 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The suction valve may not close properly which could cause continuous suction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The suction valve may not close properly which could cause continuous suction.

Code information

Lot numbers 31712, 31711, 31713, 31714, 31764, 31765, 41711, 41713, 41715, 41724, 41737, 41714, 41721, 41722, 41723, 41727, 41726, 41725, 41719, 41731, 41732, 41730, 41728, 41733, 41734, 41735, 71738, 71739, 71740, 71748, 71741, 71742, 81745, and 71743.

Distribution pattern

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

device · product 8 of 11

Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210, packaged 1/box, 12 boxes/case, single use, RX, Sterile. .

Z-2492-2018
Recall number
Z-2492-2018
Initiated
June 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The suction valve may not close properly which could cause continuous suction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The suction valve may not close properly which could cause continuous suction.

Code information

Lot numbers 41774 and 71724.

Distribution pattern

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

device · product 9 of 11

Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Manufactured For Cardinal Health, Waukegan, IL.

Z-2493-2018
Recall number
Z-2493-2018
Initiated
June 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The suction valve may not close properly which could cause continuous suction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The suction valve may not close properly which could cause continuous suction.

Code information

Lot number 41736.

Distribution pattern

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

device · product 10 of 11

Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Z-2494-2018
Recall number
Z-2494-2018
Initiated
June 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The suction valve may not close properly which could cause continuous suction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The suction valve may not close properly which could cause continuous suction.

Code information

Lot numbers 71725, 81743, 91722, and 101723.

Distribution pattern

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

device · product 11 of 11

Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Z-2495-2018
Recall number
Z-2495-2018
Initiated
June 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
A total of 63,020 valves were distributed. Specific product quantities were not provided.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The suction valve may not close properly which could cause continuous suction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The suction valve may not close properly which could cause continuous suction.

Code information

Lot numbers 21719 and 41738.

Distribution pattern

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.