Haemonetics Cell Saver Elite Kit 70ml: Leaking Centrifuge Bowl Risk
Haemonetics recalls Cell Saver Elite 70ml processing kits due to potential leaks in the centrifuge bowl during blood salvage procedures. Affected units may cause contamination or require replacement.
Lower-risk recall
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Contact the company
What happened, in plain English
Haemonetics is recalling its Cell Saver Elite 70ml processing kits because the centrifuge bowl might leak during blood salvage procedures. This could lead to contamination or the need for replacement. Read more at govinfonow.com/recall/73262-haemonetics-cell-saver-elite-kit-70ml-leaking-centrifuge-bowl-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73262-haemonetics-cell-saver-elite-kit-70ml-leaking-centrifuge-bowl-risk · Updated September 19, 2026 · FDA enforcement record: FDA #Z-0779-2019
Cite this page
“Haemonetics Cell Saver Elite Kit 70ml: Leaking Centrifuge Bowl Risk.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73262-haemonetics-cell-saver-elite-kit-70ml-leaking-centrifuge-bowl-risk. Based on FDA recall #Z-0779-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0779-2019%22&limit=1).
Why it’s dangerous
The centrifuge bowl in the 70ml kit may leak during blood processing, potentially causing contamination of the blood salvage system. This could lead to cross-contamination or require the kit to be replaced.
Who’s affected
Medical professionals using the Cell Saver Elite 70ml kit during surgeries or trauma procedures are most at risk. Patients receiving blood salvage treatments may also be affected.
How to tell if you have this one
Check for the product ID CSE-P-70 on the kit. The Cell Saver Elite 70ml kit is used for blood recovery during surgeries or trauma procedures.
- Brand
Haemonetics- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide Distribution to states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, ME, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0778-2019 | Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.; Catalog number: 0291A-00, 0291E-00 | 11,208 units |
| Z-0779-2019 | Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.; Catalog number: CSE-P-70 | 4576 units |
What to do — step by step
Check for Leaks
Inspect the centrifuge bowl for signs of leakage during blood processing.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 30 states.
FDA distribution: “US Nationwide Distribution to states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, ME, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this product?
No immediate action is required, but check for leaks and contact Haemonetics if you notice leakage.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0779-2019 (August 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0779-2019 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.