Recall Z-0597-2019 ยท KNT Tubes, Gastrointestinal (And Accessories)
COVIDIEN LLC
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.
| Date | Oct 31, 2018 |
| Status | Terminated |
| Reason | 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 | Under Investigation by firm |
| Action | 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 forwar |
| Quantity | 1522 |
| Distribution | Worldwide Distribution - US Nationwide and foreign distribution to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K810156 | ARGYLE SALEM SUMP TUBE Sherwood Medical Co., Mar 2, 1981 |