The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2951-2018·Announced 2018-09-05

Haemonetics OrthoPAT Reservoirs Recalled Due to Missing Cannula

Haemonetics is recalling 348 OrthoPAT QuickConnect Reservoirs because a missing cannula prevents blood from being emptied and processed.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the defect prevents the device from performing its intended life-supporting function.

Plain-English summary

Haemonetics Corporation is recalling 348 units of OrthoPAT System-OPAT QuickConnect Reservoirs (Product Code: OPT-R-1000, Lot # 1117066). The product was distributed nationwide in the United States.

The recall was initiated because the reservoirs are missing the cannula inside. This absence prevents the emptying of blood from the reservoirs, meaning the collected blood cannot be processed. The OrthoPAT system is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during surgical procedures.

This is a Class II recall. Users should stop using the affected units and contact Haemonetics Corporation for further instructions.

The recalled product

Product
Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The 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 — Surgical / Autotransfusion
Hazard
Affected units
348

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 (1)

  • Lot # 1117066

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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