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Recall Observatory FDA recall evidence

Device 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;

Z-3301-2024

July 24, 2024

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 95214
Status
Ongoing
Classification
Class II
Quantity
24,761,100 tubes total
Official record key
device-enforcement:Z-3301-2024

Official wording

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.

Code information: 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;

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.