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Leukotrap WB System - CP2D Package Insert

Updated:
Facts
Status:
Prescription (Rx)
Strength:
3.57 g/70 mL, 1.84 g/70 mL, 0.229 g/70 mL, 0.155 g/70 mL, 1.21 g/110 mL, 0.647 g/110 mL, 0.451 g/110 mL, 0.304 g/110 mL, 0.046 g/110 mL, 0.033 g/110 mL
Active ingredients:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Leukotrap WB System - CP2D

DESCRIPTION

CP2D/AS-3 Blood Collection and Sampling System with Nutricel Additive System

Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached SampLok Vacuum Tube Holder).

Refer to unit foil package label for specific product description being used.

Sterile, nonpyrogenic fluid path. Sterilized by steam.

Rx only.

This product is free of natural rubber latex.

INDICATIONS AND USAGE

For collection of blood and preparation of red blood cells, plasma and platelets.

WARNINGS

Failure to achieve and maintain a closed system during processing would result in a product that must be transfused within 24 hours.

GENERAL PRECAUTIONS

Use aseptic technique. Use only if solutions are clear. If preparing a platelet concentrate, the platelet-rich plasma should be separated from the red blood cells within 8 hours after blood collection. If preparing fresh frozen plasma, separate from the red blood cells and place in the freezer at -18 °C or colder within 8 hours after collection.

* During processing, always observe the following precautions:

  1. 1. Sealing should be done in a manner that avoids fluid splatter.
  2. 2. Always dispose of blood-contaminated products in a manner consistent with established BIOHAZARD safety procedures.

STORAGE

Store CP2D/AS-3 preserved red blood cells at 1—6 °C for up to 42 days and use as indicated.

If AS-3 is not used, whole blood or red blood cells in CP2D alone may be stored at 1—6 °C for up to 21 days.

PROCESSING INSTRUCTIONS

  1. 1. Process whole blood within 72 hours of collection.
  2. 2. Mix whole blood/anticoagulant thoroughly.
  3. 3. Load whole blood and satellite bags into centrifuge cup, ensuring that the tubing stays in the top half of the cup.
  4. 4. Centrifuge at appropriate conditions to produce desired components.
  5. 5. Carefully remove the unit from the centrifuge and place the red cell storage bag in the plasma expressor.
  6. 6. Clamp tubing to extra satellite bags, if present.
  7. 7. Gently apply expressor pressure.
  8. 8. Open snap-open closure to satellite bag and express plasma.
  9. 9. After plasma is expressed, clamp tubing between red cell storage bag and Y connector, and release expressor pressure.
  10. 10. Clamp tubing between the Y connector and plasma bag.
  11. 11. Hang AS-3 bag above red cell storage bag and remove clamp from tubing to the red cell storage bag.
  12. 12. Open snap-open closure on the bag containing the AS-3 additive solution and transfer to the bag containing the red cells. Note: AS-3 solution should be added to the packed red blood cells immediately after removal of plasma. Transfer AS-3 solution under one of the following processing conditions:

a. within 8 hours of collection if whole blood is held at room temperature.

b. within 72 hours of collection if whole blood is refrigerated.

  1. 13. Seal tubing and detach the bag containing packed red cells, and set aside plasma for further processing.*
  2. 14. Gently mix packed red cells and AS-3 solution.
  3. 15. Store CP2D/AS-3 preserved red blood cells at 1—6 °C for up to 42 days and use as indicated. Note: If AS-3 is not used, whole blood or red blood cells in CP2D alone may be stored at 1—6 °C for up to 21 days.

REFERENCES

Pall and Nutricel are registered trademarks of Pall Corporation. Redefining the Business of Blood is a service mark of Pall Corporation. DonorCare and SampLok are registered trademarks of ITL Corporation, Canberra, Australia.

MANUFACTURER

Medsep Corporation, A Subsidiary of Pall Corp., Covina, CA 91722, USA

Visit us at www.pall.com/medical

For Pall customer service, call: 1.800.645.6578

147120922, issued Aug. 2010

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 820915 · View the label on DailyMed

Revision date stated in the text: August 2010

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Leukotrap WB System - CP2D

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredients Dextrose monohydrate, Sodium citrate, Citric acid monohydrate, Sodium phosphate, monobasic, monohydrate
Dosage form Solution
Route Intravenous
Marketing status not in the current FDA NDC Directory
Company (applicant) Medsep Corporation
FDA approval NDA 820915New Drug Application (NDA)
Manufacturers 5 labelers list this drug on DailyMed
Packages (NDC)
Package
3.57 g/70 mL, 1.84 g/70 mL, 0.229 g/70 mL, 0.155 g/70 mL – 70 ml in 1 bag / 3 in 1 pouch / 8 in 1 box NDC 62646-120-92
1.21 g/110 mL, 0.647 g/110 mL, 0.451 g/110 mL, 0.304 g/110 mL, 0.046 g/110 mL, 0.033 g/110 mL – 110 ml in 1 bag / 3 in 1 pouch / 8 in 1 box NDC 62646-AS3-92

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.