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U.S. Department of Health and Human Services

Class 2 Device Recall CardinalHealth

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 Class 2 Device Recall CardinalHealthsee related information
Date Initiated by FirmJuly 24, 2024
Date PostedSeptember 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3302-2024
Recall Event ID 95214
510(K)NumberK880850 
Product Classification Tube, double lumen for intestinal decompression and/or intubation - Product Code FEG
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contact
888-444-5440
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionThe 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 in Commerce24,761,100 tubes total
DistributionDistribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution. Foreign distribution was made to Chile.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FEG
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