Agency classClass IIOur severity:High FDA (Devices)·Z-1678-2019·Announced 2019-06-05

Maquet Getinge Sash and Accessory Pack Recall for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific Sash & Accessory Packs because a design flaw may prevent proper sterilization of stopcock ports.

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 where the Sterility Assurance Level cannot be assured, creating a risk of harm from potential contamination, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-T 52301 Sash & Accessory Pack (Material 709000266R01). The recall covers specific batch numbers: 3000053797, 3000057760, 3000063952, 3000067187, 3000069726, 3000072683, and 3000075716. The products were distributed nationwide.

The recall is due to a potential sterilization failure. During the sterilization process, the closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from reaching the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured.

Healthcare facilities and users should identify any affected units by checking the batch numbers listed above. Users should stop using the affected Sash & Accessory Packs and contact Maquet Cardiovascular for instructions on return or replacement.

The recalled product

Product: Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical Accessories
Hazard: sterility-failure
contamination

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 183 recalled by Maquet Cardiovascular, LLC 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 183 products in this recall →

Same manufacturer · Maquet Cardiovascular, LLC

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Same hazard · sterility failure