—#168965

Product

Salem 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.

FDA product code: KNT — Tubes, Gastrointestinal (And Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K810156
Affected lot / code info: 1812115564

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On 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

Recalling firm

Firm: COVIDIEN LLC
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide and foreign distribution to Canada.

Timeline

Recall initiated: 2018-10-31
Terminated: 2020-05-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168965. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.