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Leukotrap WB System
  • Professionals
  • FDA PI

Leukotrap WB System

Generic name: cp2d/as-3
Dosage form: solution

Leukotrap WB System Description

CP2D/AS-3 Blood Bag Unit with In-Line WBF Filter and Sampling System

Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached Samp Lok 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 Leukotrap WB System

For collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction.

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. Platelet concentrates are not intended to be made with this product.

During processing, always observe the following precautions:

1. Sealing should be done in a manner that avoids fluid splatter.

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.

BLOOD COLLECTION INSTRUCTIONS FOR SYSTEMS CONTAINING A Y SAMPLING SITE (YSS) ONLY

1. Load blood agitation device or suspend blood bag on donor scale and adjust donor scale to desired collection gross weight as per manufacturer's instructions.

2. Clamp donor tubing between Donor Care® Needle Guard (DCNG) and Y Sampling Site.

3. Secure donor tubing above the Y connector and disinfect site of phlebotomy.

4. If using blood pressure cuff, inflate to not more than 60 mm Hg.

5. Remove donor needle cover and accomplish phlebotomy.

6. Release clamp and ensure there is blood flow. Reduce pressure as required.

7. Slide the DCNG midway over the needle hub and securely tape DCNG to the donor's arm as close to the top of the DCNG as possible. Note: If blood flow is slow, slide DCNG away from the needle hub, adjust and re-engage DCNG. If repeated needle adjustment is necessary, slide DCNG away from the needle hub and re-engage at the end of blood collection.

8. Collect appropriate volume of blood into colle...