The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2950-2018·Announced 2018-09-05

Haemonetics OrthoPAT System-Integrated Set Recalled Due to Missing Cannula

Haemonetics is recalling OrthoPAT System-Integrated Sets because missing cannulas prevent blood from emptying, making the collected blood unusable.

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 is classified as FDA Class II. The hazard involves a functional failure of a medical device used for blood salvage, which poses a risk of harm if the device is used as intended, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Haemonetics Corporation is recalling 432 units of the OrthoPAT System-Integrated Set (Product Code: 1150H-00) due to a manufacturing defect. The affected units are distributed nationwide in the United States.

The recall is issued because the OrthoPAT reservoirs are missing the cannula inside the reservoirs. This missing component prevents the emptying of blood from the reservoirs, which means the collected blood cannot be processed for autotransfusion.

The recall affects specific lots identified by Lot # 1017049, 1150H-00, and 1017072. Healthcare facilities and users should stop using the affected units and contact Haemonetics Corporation for further instructions on how to proceed.

The recalled product

Product
Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
Manufacturer
Haemonetics Corporation
Category
Medical Device — Blood Management
Hazard
Affected units
432

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 (3)

  • Lot # 1017049
  • 1150H-00
  • 1017072

Distribution

Distributed nationwide across the United States.

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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