Pall Sterile Cord Blood Collection Unit

Manufacturer
Haemonetics Corporation | Haemonetics Manufacturing Inc.
Effective date
2020-06-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:24:09

Label at a glance#

ProductPall Sterile Cord Blood Collection Unit
Active ingredientDEXTROSE MONOHYDRATE, SODIUM CITRATE, CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Label structure7 sections

Indications and uses

For collection of up to 210 ml of umbilical cord blood. Use aseptic technique. Contents inside overwrap pouch, within the foil envelope, are sterile and acceptable for use in a sterile field if pouch is unopened and undamaged; visual inspection to confirm the integrity of overwrap pouch should be performed.

Label contents#

Full prescribing information#

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION (CPD)

DESCRIPTION SECTION

Sterile, non-pyrogenic fluid path. Sterilized by steam.

This product is free of natural rubber latex.

Indications and Usage Section

INDICATIONS & USAGE SECTION

For collection of up to 210 ml of umbilical cord blood. Use aseptic technique.

Contents inside overwrap pouch, within the foil envelope, are sterile and acceptable for use in a sterile field if pouch is unopened and undamaged; visual inspection to confirm the integrity of overwrap pouch should be performed.

Warnings Section

WARNINGS AND PRECAUTIONS SECTION

Making multiple punctures of the umbilical cord to increase collection volume may increase the risk of contamination.

Do not irradiate collected cord blood or components.

GENERAL PRECAUTIONS

PRECAUTIONS SECTION

Do not use if the package is damaged or seal is incomplete. Use only if solution is clear.
Sealing should be done in a manner that avoids fluid splatter.

Always dispose of blood-contaminated products in a manner consistent with established BIOHAZARD safety procedures.

HOW SUPPLIED

HOW SUPPLIED SECTION

The Collection Unit inside the overwrap pouch, within the foil envelope, are sterile and acceptable for use in a sterile field if pouch is unopened and undamaged.

INFORMATION FOR PATIENTS

INFORMATION FOR PATIENTS SECTION

Visit us at www.pall.com/medical

For Pall customer service, call: 1.800.645.6578

DonorCare is a registered trademark of ITL Corporation, Canberra, Australia. Produced under license from ThermoGenesis Corp

  1. Ensure DonorCare® Needle Guard (DCNG) is positioned on the tubing between the needle hub and Pinch Clamp. Engage Pinch Clamp. Ensure tethered cap is placed securely on the air vent.
  2. Using aseptic technique, insert needle into umbilical vein, disengage Pinch Clamp to collect cord blood, mixing frequently, according to standard procedures.
  3. Upon completion of collection, engage Pinch Clamp then withdraw needle from umbilical vein. Slide the DCNG midway over the needle hub. While holding the sides of DCNG near front, grasp tubing and pull smoothly, pulling needle into the DCNG until it locks into place. Confirm that needle is locked by listening for the second click as the needle is drawn into the DCNG. Ensure that tubing cannot be pulled through DCNG.
  4. Place the bag on a work surface. While holding the tubing above the bag, open the tethered cap on the air vent. Allow the blood to drain from the tubing into the bag.
  5. When the tubing has been drained, hold tubing vertical and seal tubing directly below the Y-piece with air vent.
  6. Detach and discard needle, DCNG, Pinch Clamp, Air Vent and tubing according to standard procedures.
  7. Determine amount of anticoagulated blood collected. If required, add sedimenting agent to CPD anticoagulated blood through Sample Port using a syringe according to standard procedures.
  8. Mix well. Take care to strip and mix any blood in tubing.
  9. Load bag into centrifuge cup. It is suggested that a means of support is used to prevent bag from collapsing and to reduce wrinkles.
  10. Centrifuge according to standard procedures to obtain mononuclear cell-rich plasma.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bag LabelBag LabelPrinted Pouch LabelPrinted Pouch Label

Case LabelCase Label

IFUIFU

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53157-79153157-791-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2b14af89-bcdf-03ce-e063-6394a90a7ee5a72d2782-96cc-2a9d-e053-2995a90afc082025-01-06WarningsExact identifier
spl set id: a72d2782-96cc-2a9d-e053-2995a90afc08

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.