Recall Z-3302-2024 ยท FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Cardinal Health 200, LLC
(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
| Date | Sep 26, 2024 (initiated Jul 24, 2024) |
| Status | Open, Classified |
| Reason | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. |
| Root cause | Labeling Change Control |
| Action | 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 co |
| Quantity | 24,761,100 tubes total |
| Distribution | Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution. Foreign distribution was made to Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880850 | KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE Kmb Medical Products Co., May 26, 1988 |