PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANELFenwal(TM)Anticoagulant Citrate Dextrose Solution, USP (ACD) Formula BLOOD-PACK(TM) UnitSingle For Collection of 450 mL BloodIntegral Donor Tube, 16 ga. Ultra Thin Wall NeedleRx onlyEach unit consists of PL 146 Plastic primary container with 67.5 mL of ACD solution containing 1.65 Dextrose (monohydrate) USP, 1.48 Sodium Citrate (dihydrate) USP and 493 mg Citric Acid (anhydrous) USP.Sterile, non-pyrogenic fluid pathSee instructions for use.Store at Controlled Room Temperature (refer to direction insert). Open pouch by tearing across at notch. Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth. Unused 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, provided:l) Units are not removed from foil pouch, orll) Unused units removed from foil pouch are returned to the foil pouch within 12 hours. Units may be removed from the pouch and returned only once.FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc. Fenwal, Inc. Lake Zurich, IL 60047 USAMade in USA07-28-05-456 REV: A. Open pouch by tearing across at notch.. Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.. Unused 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, provided:l) Units are not removed from foil pouch, orll) Unused units removed from foil pouch are returned to the foil pouch within 12 hours. Units may be removed from the pouch and returned only once.. logo. Anticoagulant Citrate Dextrose Solution, USP (ACD) Formula BLOOD-PACK Unit label.

SPL UNCLASSIFIED SECTION.

Instructions for Blood Collection Using CPD or ACD Single Blood-Pack(TM) Units. Integral Donor Tube (IDT)Rx onlyUse aseptic technique.Precaution: Do not use unless solution is clear.1.Identify Blood-Pack unit using appropriate donor identification system. Confirm that all numbered tubing of each Blood-Pack unit contains its own identical segment numbers.2.Adjust donor scale to desired collection weight.3.Position primary container from donor scale as far as possible below donor arm and clamp donor tubing with hemostat.4.Apply pressure to donors arm and disinfect site of venipuncture.5.If blood pressure cuff is used, inflate to approximately 60 mmHg.6.Remove needle cover per instructions below:(a)Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.(b)Remove needle cover, being careful not to drag the cover across the needle point. Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.7.Mix blood and anticoagulant at several intervals during collection and immediately after collection.8.Collect the appropriate volume based on Blood-Pack unit used. Note: The volume of anticoagulant is sufficient for the blood collection indicated on Blood-Pack unit +- 10%.9.Apply hemostat to donor tube.10.As appropriate, release pressure on the donors arm, collect donor samples following established procedures and withdraw donor needle.Precaution: Use care to avoid accidental needle sticks. One of the Fenwal Needle Protector Systems may be used to reduce the risk of needle stick injury.Strip blood from donor tubing into container, mix and allow the tubing to refill; repeat once. Seal at marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.11.Strip blood from donor tubing into container, mix and allow the tubing to refill; repeat once. Seal at marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.12.Discard needle into an appropriate biohazardous waste container following established procedures.13.Store filled unit between and C.14.Infuse blood within 21 days of collection.Store at Controlled Room Temperature.USP Definition of Controlled Room TemperatureUnited States Pharmacopeia, General Notices.United States Phramacopeial Convention, Inc.12601 Twinbrook Parkway, Rockville, MDFenwal and Blood-Pack are trademarks of Fenwal,Inc. Manufacturer(C) 2009 Fenwal, Inc. All rights reserved. Fenwal, Inc.Lake Zurich, IL 60047 USA1-800-933-6925Made in USA07-19-02-335 REV: 02/2009 1.Identify Blood-Pack unit using appropriate donor identification system. Confirm that all numbered tubing of each Blood-Pack unit contains its own identical segment numbers.. 2.Adjust donor scale to desired collection weight.. 3.Position primary container from donor scale as far as possible below donor arm and clamp donor tubing with hemostat.. 4.Apply pressure to donors arm and disinfect site of venipuncture.. 5.If blood pressure cuff is used, inflate to approximately 60 mmHg.. 6.Remove needle cover per instructions below:(a)Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.(b)Remove needle cover, being careful not to drag the cover across the needle point.. (a)Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.. (b)Remove needle cover, being careful not to drag the cover across the needle point.. Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.. 7.Mix blood and anticoagulant at several intervals during collection and immediately after collection.. 8.Collect the appropriate volume based on Blood-Pack unit used. Note: The volume of anticoagulant is sufficient for the blood collection indicated on Blood-Pack unit +- 10%.. 9.Apply hemostat to donor tube.. 10.As appropriate, release pressure on the donors arm, collect donor samples following established procedures and withdraw donor needle.Precaution: Use care to avoid accidental needle sticks. One of the Fenwal Needle Protector Systems may be used to reduce the risk of needle stick injury.Strip blood from donor tubing into container, mix and allow the tubing to refill; repeat once. Seal at marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.. 11.Strip blood from donor tubing into container, mix and allow the tubing to refill; repeat once. Seal at marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.. 12.Discard needle into an appropriate biohazardous waste container following established procedures.. 13.Store filled unit between and C.. 14.Infuse blood within 21 days of collection.. logo. logo.