The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0778-2019·Announced 2019-02-06

Haemonetics Recalls Cell Saver 5/5+ Bowl Sets Due to Leakage

Haemonetics is recalling 11,208 units of Cell Saver 5/5+ Bowl Sets because the 70ml centrifuge bowls may leak during cell salvage processing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (leakage) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Haemonetics Corporation is recalling 11,208 units of the Cell Saver 5/5+ Bowl Set, 70ml (Product IDs: 0291E-00, 0291A-00). The recall was initiated after the company received isolated reports that the 70ml centrifuge bowl may leak during cell salvage processing.

The affected product is intended for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The units were distributed nationwide to facilities in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin.

Healthcare facilities should stop using the affected bowl sets and contact Haemonetics Corporation for instructions on how to return or dispose of the product.

The recalled product

Product
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…
Manufacturer
Haemonetics Corporation
Category
Medical Device — Surgical / Blood Processing
Hazard
Affected units
11,208

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog number: 0291A-00
  • 0291E-00

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Haemonetics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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