FDA Medical Device Recalls (openFDA)
Laerdal Medical (Suzhou) Co., Ltd.: 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.
- Recall number
- Z-0868-2021
- 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.
- Status
- Terminated
- Initiated
- 2020-12-18
- Posted
- not on file
- Terminated
- 2023-12-11
- Reason
- 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
- 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), customerservice@laerdal.com or, for Canada: (416) 298-9600, savelives@laerdal.com 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
- 5035
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Lot, serial or model codes
- Serial number range 1808090001 to 2006060045
- 510(k) numbers
- ["K120065"]
- PMA numbers
- not on file
- Product code
- JCX
- Firm FEI
- 3004993040
- Firm city
- Suzhou
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28