PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL DISPLAY PANEL. Code 4R04992 UnitsFenwal(TM)Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK(TM) UnitSingle For Collection of 450 mL of Autologous BloodRx onlyEach unit consists of PL 146 Plastic primary container with 63 mL of CPD solution containing 1.66 Sodium Citrate (dihydrate) USP, 1.61 Dextrose (monohydrate) USP, 188 mg Citric Acid (anhydrous) USP and 140 mg Monobasic Sodium Phosphate (monohydrate) USP. pH may have been adjusted with sodium hydroxide.Sterile, non-pyrogenic fluid path.See direction insert.Store at Controlled Room Temperature (refer to direction insert).oUnused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture.oDirect handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.oUnits removed from the foil pouch must be used within days (96 hours). Units out of the foil pouch for longer than days must be discarded.FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc. Fenwal, Inc.Lake Zurich, IL 60047 USAMade in USA07-28-05-649 REV: A. oUnused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture.. oDirect handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.. oUnits removed from the foil pouch must be used within days (96 hours). Units out of the foil pouch for longer than days must be discarded.. logo. Anitcoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit label.

SPL UNCLASSIFIED SECTION.

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack(TM) Unit for the Collection of 450 mL of Whole Blood for Autologous Transfusion. Instructions for useUse aseptic technique:Rx onlyNotes:oFor use with 4C2498 Y-Type Connector set with Luer connector. If an alternate set is used, follow manufacturers instructions for use.oNominal tubing dimensions of product are 0.118 inner diameter 0.025 wall thickness.oUpon removal of Blood-Pack unit from the foil pouch, visually inspect the unit.Caution: Do not use unless solutions are clear. oIdentify Blood-Pack unit using appropriate donor identification system for autologous transfusion. oOpen package containing Y-Type Connector set. Close clamps. oRemove protector from the inlet tubing of the Blood-Pack unit(s). oRemove protector from the coupler on one lead of the set by slightly pushing on one side of the cap and then pulling the cap in straight direction. Insert coupler into the inlet tubing of the Blood-Pack unit with twisting motion until firmly seated. oRepeat step with second Blood-Pack unit and the remaining lead on the Y-Type Connector set if second unit is to be collected. oPrime the set with anticoagulant from one Blood-Pack unit by slowly opening clamp on one lead of the set to permit the solution to completely fill the set. Close clamp. oPlace the Blood-Pack unit(s) in an inverted position below the level of the blood withdrawal site. oAttach lead with Luer connector to the arterial line, central venous pressure line, or peripheral venous line access. Provision should be made to replace the volume of blood collected either prior to or simultaneously with the collection in manner prescribed by the attending physician.oTo begin collection, open the clamp on the patient access line and the lead that was used to prime the Y-Type Connector set. Collect 450 mL +- 10% of blood in the first Blood-Pack unit. Mix blood and anticoagulant solution while filling. Close clamp on the lead of the Y-Type Connector set.Note:oUse scale or other appropriate means to ensure adequate collection of proper volume. oIf second unit is to be collected, open the clamp on the patient access line and the lead that was used to prime the Y-Type Connector set. Collect 450 mL +- 10% of blood in the second Blood-Pack unit. Mix blood and anticoagulant solution while filling. Close clamp on the lead of the Y-Type Connector set.Precaution: oCollection of the second unit should be initiated within approximately minutes of collection of the first unit to avoid possible clot formation in the tubing. oClose or clamp the access line to prevent blood loss or air getting into the system or patient. Disconnect the Luer connector from the access line.Precaution: oSteps 12-15 should be performed within approximately minutes after collection to avoid possible clot formation in the tubing. oIf donor samples are desired, collect donor samples following established procedures. oSeal inlet tubing of the Blood-Pack unit(s). oIf the inlet tubing is not sealed directly above the collection container, then strip the blood from the remaining inlet tubing into the collection container. Mix and allow tubing to refill; repeat once. Seal tubing at marks on the inlet tubing and leave segments attached to the collection container. oMix blood and anticoagulant solution, label and store in appropriate manner.Caution: This Blood-Pack unit is for autologous transfusion only. Blood collected should be stored at conditions appropriate for an autologous collection. Store at 1-6C and reinfuse within 24 hours of collection.FENWAL and Blood-Pack are registered trademarks of Fenwal, Inc.Fenwal, Inc.Lake Zurich, IL 60047 USAMade in USA07-19-54-238 Iss. 11/2007. oFor use with 4C2498 Y-Type Connector set with Luer connector. If an alternate set is used, follow manufacturers instructions for use.. oNominal tubing dimensions of product are 0.118 inner diameter 0.025 wall thickness.. oUpon removal of Blood-Pack unit from the foil pouch, visually inspect the unit.. oIdentify Blood-Pack unit using appropriate donor identification system for autologous transfusion. oOpen package containing Y-Type Connector set. Close clamps. oRemove protector from the inlet tubing of the Blood-Pack unit(s). oRemove protector from the coupler on one lead of the set by slightly pushing on one side of the cap and then pulling the cap in straight direction. Insert coupler into the inlet tubing of the Blood-Pack unit with twisting motion until firmly seated. oRepeat step with second Blood-Pack unit and the remaining lead on the Y-Type Connector set if second unit is to be collected. oPrime the set with anticoagulant from one Blood-Pack unit by slowly opening clamp on one lead of the set to permit the solution to completely fill the set. Close clamp. oPlace the Blood-Pack unit(s) in an inverted position below the level of the blood withdrawal site. oAttach lead with Luer connector to the arterial line, central venous pressure line, or peripheral venous line access. oTo begin collection, open the clamp on the patient access line and the lead that was used to prime the Y-Type Connector set. Collect 450 mL +- 10% of blood in the first Blood-Pack unit. Mix blood and anticoagulant solution while filling. Close clamp on the lead of the Y-Type Connector set.. oUse scale or other appropriate means to ensure adequate collection of proper volume. oIf second unit is to be collected, open the clamp on the patient access line and the lead that was used to prime the Y-Type Connector set. Collect 450 mL +- 10% of blood in the second Blood-Pack unit. Mix blood and anticoagulant solution while filling. Close clamp on the lead of the Y-Type Connector set.. oCollection of the second unit should be initiated within approximately minutes of collection of the first unit to avoid possible clot formation in the tubing. oClose or clamp the access line to prevent blood loss or air getting into the system or patient. Disconnect the Luer connector from the access line.. oSteps 12-15 should be performed within approximately minutes after collection to avoid possible clot formation in the tubing. oIf donor samples are desired, collect donor samples following established procedures. oSeal inlet tubing of the Blood-Pack unit(s). oIf the inlet tubing is not sealed directly above the collection container, then strip the blood from the remaining inlet tubing into the collection container. Mix and allow tubing to refill; repeat once. Seal tubing at marks on the inlet tubing and leave segments attached to the collection container. oMix blood and anticoagulant solution, label and store in appropriate manner.. logo.