FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888266122, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888266130, Sterile; and (d) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888266148, Sterile.
- Recall number
- Z-3302-2024
- Recalling firm
- Cardinal Health 200, LLC
- Product
- (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888266122, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888266130, Sterile; and (d) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888266148, Sterile.
- Status
- Open, Classified
- Initiated
- 2024-07-24
- Posted
- 2024-09-26
- Terminated
- not on file
- Reason
- The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
- Root cause
- Labeling Change Control
- Action
- The recalling firm issued letters dated 7/22/2024 via overnight mail on 7/24/2024. The letter informed the consignee the product labeling has been updated via electronic instructions for use for the affected product due to reported incidences of improper use of the device which can lead to breakage of the Salem Sump Anti-Reflux Valve (ARV) and an increased risk to patients. To mitigate the risk of improper use, the instructions have been revised. The risk to health and actions required were included in the letter. The actions included: (1) Review your inventory for the affected product codes; (2) Communicate the change of the use instructions with all personnel that utilize the devices; (3) Post a copy of Attachment A (the revised IFU) and the recall notification in the storeroom and clinical areas; (4) Notify any customers to whom you may have distributed/forwarded affected product or to whom you intend to distribute/forward product) regarding this medical device product correction and share a copy of the notice; (5) Return the enclosed acknowledgment form via FAX or email.
- Quantity
- 24,761,100 tubes total
- Distribution
- Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution. Foreign distribution was made to Chile.
- Lot, serial or model codes
- All lot numbers. UDI-DI numbers: (a) 8888266114, UDI-DI 10192253012781; (b) 8888266122, UDI-DI 10192253012804; (c) 8888266130, UDI-DI 10192253012828; and (d) 8888266148, UDI-DI 10192253012842.
- 510(k) numbers
- ["K880850"]
- PMA numbers
- not on file
- Product code
- FEG
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- Firm state
- IL
- 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