—#209748

Product

(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888264960, Sterile; and (d) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888264986, Sterile;

FDA product code: KNT — Tubes, Gastrointestinal (And Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K810156
Affected lot / code info: All lot numbers. UDI-DI numbers: (a) 8888264929, UDI-DI 10192253012477; (b) 8888264945, UDI-DI 10192253012491; (c) 8888264960, UDI-DI 10192253012514; and (d) 8888264986, UDI-DI 10192253012538;

Why it was recalled

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 (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution. Foreign distribution was made to Chile.

Timeline

Recall initiated: 2024-07-24
Posted by FDA: 2024-09-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209748. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.