Z-0868-2021Class II

Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 -

Name: Z-0868-2021 Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 -
Creator: Laerdal Medical (Suzhou) Co., Ltd.
Published: 2020-12-18
License: https://open.fda.gov/license/

Laerdal Medical (Suzhou) Co., Ltd. / initiated 2020-12-18 / Terminated / root cause: design

FDA source

Laerdal Medical (Suzhou) Co., Ltd. began a recall of Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent... on 2020-12-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0868-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-18
Posted: 2021-01-15
Terminated: 2023-12-11
Recalling firm: Laerdal Medical (Suzhou) Co., Ltd.
Product: 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.
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 5035
Distribution: Worldwide distribution - US Nationwide distribution.
Product codes and lots: Serial number range 1808090001 to 2006060045

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0868-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0868-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-15

Product code JCX

K120065Class IIPlaxtron Suction Unit, Model 88Aa51/88aa61 SeriesPlaxtron Industrial (M) Sdn. Bhd. / cleared 2012-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)