Anticoagulant Sodium Citrate Solution, USP, BLOOD-PACKTM Unit

Manufacturer
Fenwal, Inc. | Fenwal International, Inc.
Effective date
2021-11-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:25:24

Label at a glance#

ProductSodium Citrate Blood-Pack Units, (PL 146 Plastic)
Active ingredientTRISODIUM CITRATE DIHYDRATE
Label structure2 sections

Label contents#

Full prescribing information#

Instructions for Blood Collection and Plasmapheresis Using Double Plasmapheresis Blood-PackTM Unit

SPL UNCLASSIFIED SECTION

1. Identify Blood-Pack unit using appropriate donor identification system. Confirm that the numbers on the tubing of each Blood-Pack unit container are present and identical.2. Attach one lead of a multiple lead blood-solution recipient set to a container of 0.9% Sodium Chloride Injection, USP following instructions on recipient set carton.
3. Clamp tubing of each Blood-Pack container.
4. Remove plug from end of manifold and immediately insert needle adapter of primed
recipient set.
5. Position primary container on the donor scale as far as possible below donor arm.

6. Apply pressure to donor’s arm and disinfect site of venipuncture.

7. If blood pressure cuff is used, inflate to approximately 60 mmHg.

8. Remove needle cover and accomplish venipuncture 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.

c. Accomplish venipuncture.

9. Open clamp on tubing of one Blood-Pack container to permit flow of blood.

10. Mix blood and anticoagulant at several intervals during collection and immediately

after collection.

11. Collect specified volume of blood.

12. Release pressure as appropriate on the donor’s arm.

13. Make two seals below first number on container tubing, and sever tubing between seals.

14. Flush donor tubing with intravenous solution and adjust flow to slow drip to maintain

patency of phlebotomy needle.

15. Centrifuge container to achieve plasma-red cell separation following standard procedures.

16. Transfer plasma to an appropriate container. Seal transfer tubing in two places and sever

tubing between seals.

17. Utilize more than one identification system following standard procedures. Before infusing

red cells, confirm the identity of the intended recipient as the original donor by

comparing remaining segment numbers on severed tubing with segment number on

Blood-Pack unit. Do not rely on segment numbers alone.

18. Attach Blood-Pack unit to unused lead of recipient set. Close clamp under intravenous

solution container and open clamp on the Blood-Pack unit. Infuse red cells.

19. When red cells have been infused, flush tubing with intravenous solution.

20. Close lower clamp on recipient set.

21. If blood pressure cuff is used, inflate to approximately 60 mmHg.

22. Repeat steps 9-19 for second unit of blood.

23. Clamp tubing; remove needle from donor’s arm; bandage venipuncture site.

24. Discard bags, tubing and needle according to current guidelines for handling biohazardous

PACKAGE/LABEL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fenwal™

Anticoagulant Sodium Citrate Solution, USP, BLOOD-PACK™ Unit

Double For Collection and Processing of Two 500 mL Units of Blood 16 ga. Needle

Rx only

Each unit consists of two PL 146 Plastic containers, each with 50 mL of Anticoagulant Sodium Citrate Solution, USP containing 2 g Sodium Citrate (dihydrate) USP.

Not intended for storage or homologous transfusion of red cells.

These units should be used for plasmapheresis only.

Sterile, non-pyrogenic fluid path
See 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.

logologo Fenwal, Inc.
Lake Zurich, IL 60047 USA
Made in USA

07-28-05-516 REV: A

Y:\Drug Listings and Establishment Registration (SPL)\Drug Listings\NDA 77-923 Sodium Citrate in PL 146\4R3202MC - NDC 0942-9502-06\4R3202MC - NDC 0942-9502-06 - Version 4 - Dru...
Y:\Drug Listings and Establishment Registration (SPL)\Drug Listings\NDA 77-923 Sodium Citrate in PL 146\4R3202MC - NDC 0942-9502-06\4R3202MC - NDC 0942-9502-06 - Version 4 - Dru...

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TRISODIUM CITRATE DIHYDRATEACTIVE INGREDIENTB22547B95K6
Anhydrous Citric AcidACTIVE MOIETYXF417D3PSL6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0942-95020942-9502-06

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
TRISODIUM CITRATE DIHYDRATEB22547B95KACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a79448cc-6eb2-413e-bb5d-4d51ef911f585ce5d628-0be1-431e-b8bf-b5ef97046ec42021-11-30Exact identifier
spl id: a79448cc-6eb2-413e-bb5d-4d51ef911f58
spl set id: 5ce5d628-0be1-431e-b8bf-b5ef97046ec4

Reported adverse events (FAERS/openFDA)#

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