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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80427

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

Open FDA event record

Event summary

Timeline bucket
July 31, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ICU Medical, 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

53 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 53

119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2606-2018
Recall number
Z-2606-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number 011-C6000, Lot Number 3422869

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 2 of 53

185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2607-2018
Recall number
Z-2607-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number 011-C6031, Lot Number 3408801, 3408803, 3419007

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 3 of 53

108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2608-2018
Recall number
Z-2608-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number 011-C6047, Lot Number 3393617, 3419260

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 4 of 53

168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2609-2018
Recall number
Z-2609-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number 011-C6512, Lot Number 3370933

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 5 of 53

32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2610-2018
Recall number
Z-2610-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number 061-C6003, Lot Number 3426030

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 6 of 53

32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2611-2018
Recall number
Z-2611-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number 061-C6028, Lot Number 3414382

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 7 of 53

218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿, Check Valve, Y-Connector, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2612-2018
Recall number
Z-2612-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number 061-C6033, Lot Number 3364588

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 8 of 53

Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2613-2018
Recall number
Z-2613-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number 081-M9000R, Lot Number 3333003, 3352935, 3365932, 3383035, 3402533, 3413038

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 9 of 53

Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2614-2018
Recall number
Z-2614-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number 081-M9000R, Lot Number 3333002,3352936, 3365931, 3380288, 3402532, 3413037

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 10 of 53

112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2615-2018
Recall number
Z-2615-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B3000-75, Lot Number 3332350, 3338393, 3343644, 3352549, 3364662, 3365599, 3373893, 3378376, 3387536, 3405268, 3426053, 3428573, 3429586

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 11 of 53

137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2616-2018
Recall number
Z-2616-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B30031, Lot Number 3328524, 3338394, 3356920, 3371073, 3373902, 3405269, 3408891, 3423406

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 12 of 53

94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2617-2018
Recall number
Z-2617-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B30095, Lot Number 3352422, 3384297, 3391696, 3405273, 3416461, 3432479

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 13 of 53

88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2618-2018
Recall number
Z-2618-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B33828, Lot Number 3381499

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 14 of 53

147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2619-2018
Recall number
Z-2619-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B5216, Lot Number 3335222, 3356780, 3391845, 3401803, 3405384, 3412076, 3416485, 3416486, 3419516, 3429619, 3429620, 3432660

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 15 of 53

135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2620-2018
Recall number
Z-2620-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B90041, Lot Number 3332384, 3374220

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 16 of 53

140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2621-2018
Recall number
Z-2621-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B90065, Lot Number 3328034, 3347256, 3364748, 3374222, 3395260

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 17 of 53

84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2622-2018
Recall number
Z-2622-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B9220, Lot Number 3332388, 3335791, 3343695, 3352567, 3361526, 3364769, 3367356, 3374268, 3391911, 3402549, 3412091, 3416860, 3419590, 3429634

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 18 of 53

84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2623-2018
Recall number
Z-2623-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B9282, Lot Number 3331696, 3343698, 3344218, 3356703, 3367358, 3379230, 3381358, 3387630, 3391913, 3401825, 3416492, 3416493, 3423450, 3429635

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 19 of 53

85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2624-2018
Recall number
Z-2624-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B9405, Lot Number 3332396, 3338446, 3347144, 3371146, 3374292, 3405438, 3423451, 3426308

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 20 of 53

99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2625-2018
Recall number
Z-2625-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B9449, Lot Number 3310515, 3331699, 3331700, 3381369, 3393511, 3401836, 3405441

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 21 of 53

99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2626-2018
Recall number
Z-2626-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B9561, Lot Number 3328073, 3419595

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 22 of 53

120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2627-2018
Recall number
Z-2627-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B9622, Lot Number 3327623, 3332856, 3338452, 3351761, 3355549, 3371150, 3373269, 3374329, 3384355, 3387646, 3391948, 3401837, 3405445, 3408966, 3423453

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 23 of 53

121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2628-2018
Recall number
Z-2628-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B9752, Lot Number 3336049, 3351027, 3352504, 3389728, 3391951, 3412098, 3419605, 3423455

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 24 of 53

132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2629-2018
Recall number
Z-2629-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B9756, Lot Number 3352552, 3364782, 3371152, 3374346, 3384365, 3396189, 3402557, 3405457, 3408968, 3412099, 3423456, 3426318

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 25 of 53

175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2630-2018
Recall number
Z-2630-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B9757, Lot Number 3371153

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 26 of 53

140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2631-2018
Recall number
Z-2631-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number B9772, Lot Number 3328076, 3343706, 3351028, 3359075, 3364783, 3373275, 3387655, 3391953, 3396191, 3408969, 3423458

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 27 of 53

100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2632-2018
Recall number
Z-2632-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number K098-001, Lot Number 3332425, 3364299, 3396263

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 28 of 53

125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2633-2018
Recall number
Z-2633-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number MC330414, Lot Number 3401939

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 29 of 53

164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2634-2018
Recall number
Z-2634-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number MC33481, Lot Number 3332863, 3344272, 3356773, 3367490, 3371297, 3389253, 3396288, 3419674, 3426437

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 30 of 53

105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2635-2018
Recall number
Z-2635-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number MRSB-105, Lot Number 3254697, 3296639, 3309836, 3310605

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 31 of 53

94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2636-2018
Recall number
Z-2636-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number MRSB-94, Lot Number 3254698, 3274464, 3281536, 3293649, 3306431, 3307309, 3310606, 3338586

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 32 of 53

80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2637-2018
Recall number
Z-2637-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z0878, Lot Number 69-333-SJ, 69-703-SJ, 70-417-SL, 70-939-SJ, 71-366-Y1, 71-898-Y1, 72-280-HE

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 33 of 53

162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2638-2018
Recall number
Z-2638-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z1278, Lot Number 70-577-SL, 70-753-SL, 71-103-Y1, 71-193-Y1, 71-536-Y1, 71-704-Y1, 71-989-Y1, 72-409-HE, 72-538-HE, 72-555-HE, 72-928-HE, 73-176-HE, 73-393-HE, 73-623-HE, 73-871-HE, 74-613-JW, 74-713-JW, 75-088-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 34 of 53

128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, Removable 2 Gang (Blue, Yellow) 1o2¿ Manifold, Baseplate, 1 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2639-2018
Recall number
Z-2639-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z1340, Lot Number 72-391-HE, 73-994-HE

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 35 of 53

112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2640-2018
Recall number
Z-2640-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z1440, Lot Number 69-334-SJ, 70-212-SL, 70-913-SL, 70-937-SJ, 71-660-Y1, 72-392-HE, 72-620-HE, 72-905-HE, 73-158-HE, 73-389-HE, 73-625-HE, 73-995-HE, 74-006-JW, 74-307-JW, 74-453-JW, 74-714-JW, 75-430-JW, 75-656-JW, 75-834-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 36 of 53

88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2641-2018
Recall number
Z-2641-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z1646, Lot Number 69-335-SJ, 71-178-Y1, 73-160-HE, 74-716-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 37 of 53

100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2642-2018
Recall number
Z-2642-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z1689, Lot Number 69-352-SJ, 69-741-SJ, 70-969-SJ

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 38 of 53

99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2643-2018
Recall number
Z-2643-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z1726, Lot Number 69-705-SJ, 71-809-Y1

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 39 of 53

99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2644-2018
Recall number
Z-2644-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z2001, Lot Number 70-412-SL, 71-175-Y1, 71-693-Y1, 73-163-HE, 73-842-HE, 74-718-JW, 74-991-JW, 75-582-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 40 of 53

98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2645-2018
Recall number
Z-2645-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z2449, Lot Number 75-760-JW, 75-958-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 41 of 53

132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2646-2018
Recall number
Z-2646-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z2451, Lot Number 70-208-SL, 71-173-Y1, 72-647-HE, 72-907-HE, 73-629-HE, 74-456-JW, 74-721-JW, 75-434-JW, 75-761-JW, 75-959-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 42 of 53

134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2647-2018
Recall number
Z-2647-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z2717, Lot Number 72-895-HE, 73-182-HE, 73-874-HE, 74-010-JW, 75-762-JW, 75-839-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 43 of 53

143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2648-2018
Recall number
Z-2648-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z2819, Lot Number 69-338-SJ, 72-415-HE

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 44 of 53

159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2649-2018
Recall number
Z-2649-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z2902, Lot Number 69-365-SJ, 69-707-SJ, 70-196-SL, 70-400-SL, 70-759-SL, 70-918-SL, 70-952-SJ, 71-189-Y1, 71-562-Y1, 71-669-Y1, 71-861-Y1, 73-604-HE, 73-877-HE, 74-014-JW, 74-320-JW, 74-463-JW, 74-733-JW, 75-262-JW, 75-420-JW, 75-644-JW, 75-846-JW, 76-096-SJ

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 45 of 53

115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2650-2018
Recall number
Z-2650-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z3172, Lot Number 69-859-JW, 71-573-Y1, 72-148-HE, 73-408-HE, 74-103-JW, 75-322-JW, 75-645-JW, 76-107-SJ

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 46 of 53

139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pierced Port, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2651-2018
Recall number
Z-2651-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z3267, Lot Number 71-008-HE, 71-530-Y1, 71-732-Y1, 72-621-HE, 72-929-HE, 73-008-JW, 73-186-HE, 74-459-JW, 74-740-JW, 75-174-JW, 75-637-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 47 of 53

125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2652-2018
Recall number
Z-2652-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z3417, Lot Number 69-204-SJ, 70-920-SL, 71-002-HE, 72-138-HE, 72-648-HE, 73-397-HE, 73-680-HE, 74-012-JW, 74-323-JW, 75-175-JW, 75-860-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 48 of 53

98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2653-2018
Recall number
Z-2653-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z3465, Lot Number 72-139-HE, 73-646-HE, 75-267-JW, 75-437-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 49 of 53

126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2654-2018
Recall number
Z-2654-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z3521, Lot Number 74-350-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 50 of 53

107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2655-2018
Recall number
Z-2655-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z3550, Lot Number 71-567-Y1, 73-648-HE, 73-862-HE, 75-167-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 51 of 53

117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2656-2018
Recall number
Z-2656-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z3843, Lot Number 70-973-SJ, 71-474-Y1, 73-006-JW, 73-641-HE, 74-340-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 52 of 53

116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2657-2018
Recall number
Z-2657-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z4088, Lot Number 3429743

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

device · product 53 of 53

120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Z-2658-2018
Recall number
Z-2658-2018
Initiated
July 31, 2017
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
160,016 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information

Item Number Z4089, Lot Number 69-717-SJ, 70-260-SL, 73-197-HE, 74-725-JW

Distribution pattern

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.