Haemonetics Corporation: 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.; 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 lo

Agency Publication Date: January 29, 2020

Affected Products

Product: 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.

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.

Lot Numbers:

number

Product: 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.

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.

Product: 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.

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.

Lot Numbers:

number

Product: 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.

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.

Lot Numbers:

numbers

Product: 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.

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.

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numbers

Product: 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.

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.

Product: 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.

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.

Lot Numbers:

numbers

Product: 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.

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.

Lot Numbers:

numbers

Product: 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.

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.

Lot Numbers:

number

Product: 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.

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.

Lot Numbers:

numbers

Product: 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.

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.

Lot Numbers:

number

Product: 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.

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.

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numbers

Product: 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.

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.

Lot Numbers:

with

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Product: 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.

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.

Lot Numbers:

with

number

Product: 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.

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.

Lot Numbers:

numbers

Product: 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.

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.

Lot Numbers:

number

Product: 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.

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.

Lot Numbers:

number

Product: 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.

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.

Lot Numbers:

numbers

Product: 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.

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.

Product: 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.

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.

Lot Numbers:

number

Product: 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

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.

Lot Numbers:

number

Product: 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

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.

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84183

Status: Resolved

Manufacturer: Haemonetics Corporation

Manufactured In: United States

Units Affected: 22 products (44821; 333443; 3563; 14095; 1340; 8641; 690043; 257345; 176742; 1092; 42739; 14698; 38699; 28462; 25529; 739; 14278; 8114; 21113; 12370; 14271; 1584)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

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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.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84183

Status: Resolved

Manufacturer: Haemonetics Corporation

Manufactured In: United States

Units Affected: 22 products (44821; 333443; 3563; 14095; 1340; 8641; 690043; 257345; 176742; 1092; 42739; 14698; 38699; 28462; 25529; 739; 14278; 8114; 21113; 12370; 14271; 1584)