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Salem Sump recallZ-3302-2024 · Cardinal Health 200, LLC · initiated Jul 24, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Labeling Change Control

What the company is doing

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.

Recall details

Recall number
Z-3302-2024
Status
Open, Classified
Initiated by the company
Jul 24, 2024
Posted by the FDA
Sep 26, 2024
Recalling firm
Cardinal Health 200, LLC
Quantity
24,761,100 tubes total
Product code
FEG
FDA submissions
K880850
Distribution
Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution. Foreign distribution was made to Chile.

Product description

(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.

Code information (models, lots, serial numbers)

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.

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95214).

Sources and updates

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