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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85691

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

Open FDA event record

Event summary

Timeline bucket
June 30, 2020
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
CareFusion 303, 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

8 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 8

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

Z-2716-2020
Recall number
Z-2716-2020
Initiated
June 30, 2020
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
37141

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

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

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

Code information

During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers. ** US Serial numbers: 2326370, 2326382, 2326385, 2326387, 3668143, 2326400, 2326401, 2326402, 2326416, 2326418, 2326419, 2326423, 2326647, 2326664, 2326819, 2326821, 2326834, 2326837, 2326842, 2326873, 2326882, 2326883, 2326926, 9300064, 9300081, 9300083, 9300117, 9300149, 9300162, 9300163, 9300164, 9300171, 9300174, 9300176, 9300284, 9300302, 9300313, 9300317, 9300333, 9300334, 9300485, 3669844, 9300531, 9300532, 9300533, 9300534, 9300535, 9300538, 3686560, 4011408, 3696229, 3000933, 4122102, 4123517, 4123611, 4123651, 4123981, 4124350, 4124764, 4124999, 4125045, 4125149, 4125888, 4125923, 4126044, 4126051, 4126072, 4126073, 4126076, 4126077, 4126092, 4126093, 4126127, 4126128, 4126131, 4126146, 4126147, 4126148, 4126149, 4126151, 4126205, 4126206, 4126208, 4126212, 4126213, 4126214, 4126285, 4126286, 4126287, 4126288, 4126290, 4126299, 4126302, 4126315, 4126318, 4126358, 4126360, 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9895970, 9895978, 9895984, 9895987, 9896005, 9896024, 9896025, 9896038, 9896041, 9896046, 9896049, 9896052, 9896061, 9896063, 9896099, 9896102, 9896103, 9896114, 9896117, 9896121, 9896125, 9896128, 9896131, 9896132, 9896137, 9896138, 9896140, 9896141, 9896142, 9896149, 9896150, 9896151, 9896163, 9896164, 9896165, 9896167, 9896180, 9896181, 9896182, 9896184, 9896196, 9896197, 9896212, 9896213, 9896214, 9896215, 9896227, 9896228, 9896229, 9896230, 9896231, 9896254, 9896255, 9896256, 9896257, 9896258, 9896276, 9896278, 9896284, 9896285, 9896295, 9896296, 9896297, 9896298, 9896299, 9896319, 9896320, 9896321, 9896332, 9896333, 9896334, 9896366, 9896368, 9896369, 9896370, 9896371, 9896375, 9896384, 9896385, 9896407, 9896410, 9896416, 9896419, 9896421, 9896434, 9896435, 9896444, 9896448, 9896473, 9896481, 9896486, 9896489, 9896499, 9896501, 9896502, 9896510, 9896511, 9896523, 9896524, 9896541, 9896542, 9896547, 9896552, 9896554, 9896558, 9896570, 9896576, 9896578, 9896582, 9896583, 9896584, 9896587, 9896588, 9896589, 9896598, 9896599, 9896600, 9896601, 9896616, 9896617, 9896618, 9896626, 9896627, 9896628, 9896629, 9896650, 9896652, 9896685, 9896701, 9896702, 9896703, 9896704, 9896726, 9896731, 9896735, 9896736, 9896737, 9896739, 9896754, 9896755, 9896756, 9896781, 9896783, 9896788, 9896801, 9896809, 9897116, 9897118, 9897126, 9897134, 9897139, 9897140, 9897142, 9897172, 9897175, 9897176, 9897207, 9897222, 9897225, 9897236, 9897237, 9897267, 9897268, 9897512, 9897514, 9897523, 9897528, 9897529, 9897530, 9897565, 9897566, 9897567, 9897591, 9897594, 9897595, 9897596, 9897619, 9897637, 9897666, 9897667, 9897668, 9897669, 9897680, 9897688, 9897689, 9897711, 9897714, 9897717, 9897732, 9897741, 9897744, 9897748, 9897764, 9897781, 9897790, 9897803, 9897819, 9897820, 9897838, 9897861, 9897871, 9897883, 9897899, 9897905, 9897936, 9897946, 9897950, 9897966, 9897991, 9898029, 9898032, 9898033, 9898034, 9898035, 9898047, 9898066, 9898067, 9898072, 9898073, 9898095, 9898096, 9898100, 9898101, 9898111, 9898127, 9898128, 9898142, 9898169, 9898180, 9898181, 9898182, 9898186, 9898191, 9898235, 9898256, 9898263, 9898280, 9898282, 9898290, 9898291, 9898292, 9898296, 9898319, 9898334, 9898340, 9898341, 9898355, 9898357, 9898360, 9898370, 9898371, 9898403, 9898430, 9898434, 9898458, 9898487, 9898488, 9898519, 9898533, 9898535, 9898538, 9898542, 9898543, 9898563, 9898581, 9898584, 9898597, 9898598, 9898605, 9898610, 9898876, 9898883, 9898884, 9898900, 9898910, 9898911, 9898942, 9898966, 9898968, 9898991, 9898992, 9898993, 9899012, 9899013, 9899055, 9899056, 9899057, 9899058, 9899059, 9899072, 9899092, 9899095, 989

Distribution pattern

Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH

device · product 2 of 8

Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system

Z-2717-2020
Recall number
Z-2717-2020
Initiated
June 30, 2020
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
824277

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

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

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

Code information

During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers. US and OUS serial numbers:

Distribution pattern

Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH

device · product 3 of 8

Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

Z-2718-2020
Recall number
Z-2718-2020
Initiated
June 30, 2020
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
1332354

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

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

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

Code information

During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.

Distribution pattern

Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH

device · product 4 of 8

Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system

Z-2719-2020
Recall number
Z-2719-2020
Initiated
June 30, 2020
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
122423

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

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

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

Code information

During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.

Distribution pattern

Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH

device · product 5 of 8

Alaris PCA Module Model 8120, a modular infusion pump and monitoring system

Z-2720-2020
Recall number
Z-2720-2020
Initiated
June 30, 2020
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
83532

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

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

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

Code information

During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.

Distribution pattern

Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH

device · product 6 of 8

Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system

Z-2721-2020
Recall number
Z-2721-2020
Initiated
June 30, 2020
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
38982

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

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

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

Code information

During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.

Distribution pattern

Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH

device · product 7 of 8

Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system

Z-2722-2020
Recall number
Z-2722-2020
Initiated
June 30, 2020
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
7854

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

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

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

Code information

During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.

Distribution pattern

Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH

device · product 8 of 8

Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system

Z-2723-2020
Recall number
Z-2723-2020
Initiated
June 30, 2020
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
17767

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

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

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

Code information

During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.

Distribution pattern

Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH