(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model

FDA device recall Z-3302-2024 · posted 2024-09-26 · Open, Classified

Recall details

Recalling firm

Cardinal Health 200, LLC

Reason for recall

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

Action taken

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.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

FEG

Quantity affected

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.

Date initiated

2024-07-24

Date posted

2024-09-26

Location

Waukegan, IL

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