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U.S. Department of Health and Human Services

Class 2 Device Recall Salem Sump Dual Lumen Stomach Tubes

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 Class 2 Device Recall Salem Sump Dual Lumen Stomach Tubessee related information
Date Initiated by FirmOctober 31, 2018
Create DateDecember 11, 2018
Recall Status1 Terminated 3 on May 26, 2020
Recall NumberZ-0597-2019
Recall Event ID 81560
510(K)NumberK810156 
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductSalem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and to prevent the distention of the stomach.
Code Information 1812115564
Recalling Firm/
Manufacturer		 COVIDIEN LLC
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information ContactCardinal Health Customer Service
800-292-9332
Manufacturer Reason
for Recall		This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the potential to affect patient care, particularly in an emergency situation where the correct size is not readily available.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn October 31, 2018, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the incorrect packaging issue. Action Required: 1. INSPECT your inventory for the affected product code and lot number (listed on package) 2. SEGREGATE and QUARANTINE all on-hand product 3. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product youve quarantined or discarded. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall 5. CONTACT the appropriate Customer Service group to arrange for return and credit of any affected product: Hospital800-964-5227 Federal Government800-444-1166 Distributor800-635-6021 All other customers888-444-54401
Quantity in Commerce1522
DistributionWorldwide Distribution - US Nationwide and foreign distribution to Canada.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KNT
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