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Terminated

Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.

FDA Recall Z-0868-2021 · Posted None

Recall StatusTerminated
Product CodeJCX
Date Initiated2020-12-18
Date Terminated2023-12-11
Product Quantity5035

Reason for Recall

Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user.

Firm Action

On December 18, 2020, the firm sent Urgent Medical Device Recall letters to affected customers. Customers were informed that the service life of the LCSU 4 may be reduced. Customers were asked to identify and secure affected units. Customers were told that they could continue to use their LCSU 4 unit until they receive a replacement unit, but were provided with safety measures: - Follow local protocols for back-up suction devices. Do not repeatedly block the patient tube for more than 10 seconds at a time at vacuum levels greater than 300 mmHg. - Only use canisters, tubes and accessories that are approved for the device by Laerdal Medical. - When adjusting the vacuum level: When the desired vacuum level is reached; unblock the patient tube immediately. - During patient treatment do not occlude or block the patient tube by intentional bending or squeezing. The patient tube should only be temporarily occluded by suctioning matter. - When performing the Device Test: When the vacuum reaches minimum 500 mmHg immediately release the blocking. - If your affected LCSU 4 experiences a loss of peak suction, please report this to your local Laerdal Sales office, for US: 877-LAERDAL (523-7325), [email protected] or, for Canada: (416) 298-9600, [email protected] Customers must complete the included reply form to acknowledge receipt of the recall notice and to identify any units needing replacement, and return the information to Stericycle.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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