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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84183

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

Open FDA event record

Event summary

Timeline bucket
October 21, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Haemonetics Corporation

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

22 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 22

CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

Z-0885-2020
Recall number
Z-0885-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
44821

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 00260-00 1. Specific Lots with Bowl Cracks (6920 Distributed) Lot numbers: 1907006HTT 1902005HTT 1902008HTT 1902011HTT 1906005HTT 1803013HTT 1804004HTT 1804006HTT 1804002HTT 1804009HTT 1805002HTT 1805003HTT 1811002HTT 1812010HTT 812011HTT 1901001HTT 1812005HTT 1812008HTT 1901007HTT 1808006HTT 1808010HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 2 of 22

CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

Z-0886-2020
Recall number
Z-0886-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
333443

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 00261-00 1. Specific Lots with Bowl Cracks (8111 Distributed) Lot numbers: 0119008 0719045 0819016 1118051 1118006 0919022 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 3 of 22

High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

Z-0887-2020
Recall number
Z-0887-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
3563

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 0263A-00 1. No lots for cracking issue identified (0 Distributed). 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 4 of 22

CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

Z-0888-2020
Recall number
Z-0888-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
14095

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 00265-00 1. Specific Lots with Bowl Cracks (720 distributed) Lot numbers: 1812011HTT 1902006HTT 1902007HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 5 of 22

CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

Z-0889-2020
Recall number
Z-0889-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
1340

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 0265F-00 1. No specific lots with bowl cracks. 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 6 of 22

CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

Z-0890-2020
Recall number
Z-0890-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
8641

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 00260F-00 1. Specific Lots with Bowl Cracks (172 distributed) Lot number: 1902010HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 7 of 22

Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

Z-0891-2020
Recall number
Z-0891-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
690043

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 00263-00 1. Specific Lots with Bowl Cracks (44831 Distributed) Lot number: 0119010 0119011 0219031 0218056 0218057 0218058 0418012 1018084 1118009 0718099 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 8 of 22

CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

Z-0892-2020
Recall number
Z-0892-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
257345

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: CSE-P-225 1. Specific Lots with Bowl Cracks (37248 Distributed) Lot numbers: 0718008 0818052 0818110 0119048 0218064 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 9 of 22

CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

Z-0893-2020
Recall number
Z-0893-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
176742

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: CSE-P-125 1. Specific Lots with Bowl Cracks (10856 Distributed) Lot number: 0119014 0119015 0719047 0719060 0819014 0819032 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 10 of 22

CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

Z-0894-2020
Recall number
Z-0894-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
1092

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: CSE-FP-225F 1. Specific Lots with Bowl Cracks (452 Distributed) Lot numbers: 1901003HTT 1810008HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 11 of 22

CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

Z-0895-2020
Recall number
Z-0895-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
42739

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: CSE-FP-225V 1. Specific Lots with Bowl Cracks (7636 Distributed) Lot number: 1902009HTT 1903001HTT 1903004HTT 1804008HTT 1804010HTT 1805004HTT 1805005HTT 1812012HTT 1901004HTT 1901005HTT 1901006HTT 1808007HTT 1808009HTT 1808012HTT 1809001HTT 1809002HTT 1809006HTT 1809009HTT 1810001HTT 1810003HTT 1901005HTT 1902009HTT 1810006HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 12 of 22

CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

Z-0896-2020
Recall number
Z-0896-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
14698

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: CSE-FP-125V 1. Specific Lots with Bowl Cracks (959 Distributed) Lot numbers: 1902003HTT 1902002HTT 1909003HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 13 of 22

JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit.

Z-0897-2020
Recall number
Z-0897-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
38699

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: FG - 0261J-00 1. Specific Lot with Bowl Cracks (446 Distributed) Lot number: 118011 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 14 of 22

JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit.

Z-0898-2020
Recall number
Z-0898-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
28462

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 0263J-00 1. Specific Lot with Bowl Cracks (814 Distributed) Lot number: 0718027 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 15 of 22

JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit.

Z-0899-2020
Recall number
Z-0899-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
25529

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 261J-SET 1. Specific Lots with Bowl Cracks (1819 Distributed) FP Lot numbers: 1118011-0119029-190124H2; 1118011-0119030-190125H1; 1118011-1118031-181226H1; 1118011-1118032-181226H1; 1118011-1118081-190124H1; 1118011-1118082-190124H1; 1118011-1118082-190124H2; 1118011-1118083-190124H2 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 16 of 22

JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit.

Z-0900-2020
Recall number
Z-0900-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
739

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 261J-SS-SET 1. Specific Lots with Bowl Cracks (17 Distributed) Lot number: 1118011-111808108170710119002 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 17 of 22

Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

Z-0901-2020
Recall number
Z-0901-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
14278

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: CSE-FP-125V-JA 1. Specific Lots with Bowl Cracks (64 Distributed) Lot number: 0719048-0219057190329H10119100 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 18 of 22

JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

Z-0902-2020
Recall number
Z-0902-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
8114

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: CSE-FP-225V-JA 1. Specific Lots with Bowl Cracks (1249 Distributed) FP Lot numbers: 1118017-0219057190124H10119084; 1118017-1118031181226H11118019; 1118017-1118031181226H11118063; 1118017-1118032181226H11118063; 1118017-1118081190124H10119084; 1118017-1118082190124H10119002; 1118017-1118082190124H20119002; 1118017-1118083190124H20119084 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 19 of 22

JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

Z-0903-2020
Recall number
Z-0903-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
21113

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: CSE-P-125-JA 1. No Specific Lots with Bowl Cracks (0 Distributed) 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 20 of 22

JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

Z-0904-2020
Recall number
Z-0904-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
12370

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: CSE-P-225-JA 1. Specific Lots with Bowl Cracks (565 Distributed) Lot number: 1118017, 0718009 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 21 of 22

Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma

Z-0905-2020
Recall number
Z-0905-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
14271

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 263J-SET 1. Specific Lots with Bowl Cracks (1382 Distributed) FP Lot number: 0718027-0119029-190124H2; 0718027-0119029-190125H1; 0718027-0818085-181030H1; 0718027-0818086-181030H1; 0718027-1018006-181224H1; 0718027-1018007-181224H1; 0718027-1018008-181225H1; 0718027-1018009-181226H1; 0718027-1118031-181226H1; 0718027-1118032-181226H1; 0718027-1118081-190124H1; 0718027-1118083-190124H2 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

device · product 22 of 22

Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma

Z-0906-2020
Recall number
Z-0906-2020
Initiated
October 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Haemonetics Corporation
Quantity
1584

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

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

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Code information

Catalog number/FG Item Number: 263J-SS-SET 1. Specific Lots with Bowl Cracks (110 Distributed) Lot number: 0718027-0119029-08170710119003; 0718027-0818086-08170711018045; 0718027-1118031-08170711118019; 0718027-1118081-08170710119084 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.