Cord Blood Collection Kit: Contents and FDA Rules

General product and regulatory information only, not medical advice. This page does not describe how to collect cord blood and does not replace a kit’s own instructions for use or a facility’s protocols.

A cord blood collection kit is a labeled, single-use, sterile collection unit: an anticoagulant-containing bag with tubing and one or more needles, supplied under a manufacturer’s label. This page is for procurement, quality and supply staff who need to know what a kit’s label says it contains and which questions sit with the kit versus the cord blood establishment. After reading it you can check an incoming kit’s label against the checklist below and see which US rules apply to the unit once it is collected.

Purpose and setting

The two manufacturer labels compared on this page (US DailyMed label text) describe the product as a unit for collecting umbilical cord blood using aseptic technique. Both are prescription-only (Rx only) labels. Where a kit is used, who may use it and what happens to the unit afterwards are decided by the facility and the receiving cord blood bank, not by the kit. For wider context on supply planning in related settings see birthing center supply checklist, home birth midwife practice supply checklist and umbilical cord clamp types.

What is in a labeled cord blood collection kit?

There is no single standard kit. The table compares two real labeled units; contents differ by manufacturer and model, so the label of the unit you receive governs.

Item	Pall/Medsep Sterile Cord Blood Collection Unit (791-08)	Macopharma MSC128D	Why it matters
Anticoagulant	35 ml Anticoagulant Citrate Phosphate Dextrose Solution (CPD)	21 mL CPD in the collection bag	Each label states the CPD volume together with the maximum collection volume.
Labeled collection volume	Up to 210 ml of umbilical cord blood	Up to 200 mL of umbilical cord blood	Indication statement on each label.
Collection bag	Not stated in the label text	300 mL collection bag	Bag capacity is stated only on the MSC128D label.
Rinsing bag	None listed	40 mL rinsing bag with CPD	Present in the MSC128D design only.
Needles	Not stated in the label text; the instructions refer to a needle guard accessory	Two 12 gauge needles, each with a protective shield (SECUVAM)	Needle count and gauge are stated only on the MSC128D label.
Other listed items	Pinch clamp, air vent with tethered cap, sample port (named in the instructions)	Clamps 3A, 3B and 3C; graduation label as a visual aid to approximate volume	Components named in each manufacturer’s own documents.
Sterility	Sterile, non-pyrogenic fluid path, sterilized by steam; contents inside the overwrap pouch are sterile if the pouch is unopened and undamaged	Sterile, non-pyrogenic fluid path, sterilized by steam; only contents inside the inner wrap are sterile if the pouch is unopened and undamaged	Both labels tie sterility to an intact package.
Natural rubber latex	Free of natural rubber latex	Not made with natural rubber latex	Each label makes a latex statement.
Manufacturer	Medsep Corporation, a subsidiary of Pall Corp. (label issued August 2010)	Maco Productions Polonia, distributed in the USA by Macopharma USA	Identifies who holds the label.

Documents to ask for when accepting a kit

Drawn from what the two labels above actually state, an incoming-kit review can check that the supplier provides:

the current instructions for use and label, including the maximum labeled collection volume;
the anticoagulant name and its volume per unit (CPD in both labels);
the sterility statement and the package-integrity conditions it depends on;
the natural rubber latex statement;
the handling window and temperature range, if the manufacturer states one (see below);
the printed expiry or lot information on the kit itself.

What varies by facility type

The labels and FDA documents cited here do not set different kit contents for public cord blood banks, private banks or hospitals, and this page does not infer any. What the labels do show is variation by manufacturer and model, as in the table: different CPD volumes, bag sizes, needle counts and a rinsing bag in one design only. For how a site standardizes collection kits across locations, see specimen collection kit standardization in multi-site trials.

Storage, expiry and restocking

The Macopharma MSC128D label recommends keeping cord blood at ambient temperature (18-26 °C) or cold temperature (4-12 °C) and processing within 48 hours of collection, and within 24 hours if the collection volume is under 60 mL. It describes the kit as single use and says not to use it if the overwraps or bags show signs of alteration. The Pall/Medsep 791-08 label says not to use the unit if the package is damaged or the seal is incomplete. Neither label text gives a storage condition or shelf life for the unopened kit, so the printed label on the unit and the supplier’s documents govern expiry and restocking. The MSC128D warnings also state: avoid contact with sharp objects; do not irradiate collected cord blood or components.

Standards and rules that apply

21 CFR 1271.265 (receipt, predistribution shipment and distribution of an HCT/P; Legal Information Institute copy of the eCFR, checked 2026-11-01). It covers evaluating incoming HCT/Ps and accepting, rejecting or quarantining them on pre-established criteria, and shipment in quarantine when a unit is not available for distribution. Paragraph (d) states that packaging and shipping containers must be designed and constructed to protect the HCT/P from contamination, and that shipping conditions must be established for each type of HCT/P. This section does not contain collection or kit-labeling requirements, and it applies to the establishment handling the HCT/P rather than to the kit as a product.
FDA, Frequently Asked Questions About Minimally Manipulated Unrelated Cord Blood Products for Clinical Use (page dated 3/26/2012, updated 01/26/2018; checked 2026-11-01). Cord blood units are available under an approved biologics license application or an investigational new drug application; unlicensed units may be available through expanded access under 21 CFR 312.300; units from donors whose eligibility determination is incomplete fall under 21 CFR 1271.60; and units from ineligible donors under 21 CFR 1271.65, only where there is documented urgent medical need as defined in 21 CFR 1271.3(u).

In short, the kit’s label answers what the device contains and how its manufacturer says it is to be handled. Donor eligibility, quarantine and shipping duties belong to the establishment handling the cord blood unit. Related background: biospecimen and blood bank and transfusion service supply checklist.

FAQ

What does a cord blood collection kit contain?

It depends on the model. The Pall/Medsep 791-08 label lists 35 ml CPD for up to 210 ml of cord blood; the Macopharma MSC128D contains a 300 mL collection bag with 21 mL CPD, a 40 mL rinsing bag, two 12 gauge needles with protective shields and a graduation label (labels checked 2026-11-01).

Is a cord blood collection kit sterile?

Both labels describe a sterile, non-pyrogenic fluid path sterilized by steam, with sterility of the contents depending on the pouch being unopened and undamaged.

Do the kits contain latex?

The 791-08 label says the product is free of natural rubber latex and the MSC128D label says it is not made with natural rubber latex. Check the label of the specific kit you receive.

How long can collected cord blood wait before processing?

The MSC128D label recommends processing within 48 hours of collection, or within 24 hours when under 60 mL is collected, kept at 18-26 °C or 4-12 °C. Other manufacturers and receiving banks may state different windows, so use the documents for your unit.