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Terminated

In-Line ventilator adaptor

FDA Recall Z-1138-2022 · Posted 2022-05-30

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeNHJ
Date Initiated2022-04-26
Date Terminated2024-08-20
Product Quantity259 units

Reason for Recall

There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

Firm Action

The recall notification was sent to consignees on 04/26/2022 via FedEx. The customer was instructed to sign acknowledgement form to confirm receipt and return to Hillrom using pre-paid envelope.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200988Maximus SystemHill-Rom Services Pte, Ltd. · 2020-05-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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