FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
- Recall number
- Z-0018-2025
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
- Status
- Open, Classified
- Initiated
- 2024-06-26
- Posted
- 2024-10-18
- Terminated
- not on file
- Reason
- Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
- Root cause
- Process control
- Action
- Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 06/26/2024 via mail. The notice explained the issue, potential risks, and requested the affected product be quarantined, and the response for returned to initiate the return and replacement process. Distributors were directed to notify their customers. For further inquires: Product complaints or adverse events: productcomplaints@icumed.com 1-(866)-216-8806 Additional information or technical assistance 1-(800)-241-4002, option 3 tsc.support@icumed.com
- Quantity
- 120960 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- UDI/DI 30610586044186, Lot Numbers: 3997242-ENG, 4040002AB, 4040000AB, 4040001AB, 4040008AB, 4040007AB, 4040009AB, 4146021AB
- 510(k) numbers
- ["K081156"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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