Recall Z-0936-2018 ยท GAZ Tubing, Noninvasive
Medtronic Minimally Invasive Therapies Group
Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, n
| Date | Mar 5, 2018 (initiated Oct 24, 2017) |
| Status | Terminated |
| Reason | Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing. |
| Root cause | Packaging process control |
| Action | An URGENT MEDICAL DEVICE RECALL letter was issued to customers on October 24, 2017. This letter notified customers of the products subject to the recall and stated the following: The primary package labeling (Label closest to the product) may be incorrect. Customers can identify the affected product by consulting Attachment B. Please quarantine and return any unused products of the item codes and lot detailed above. Unused products from the affected item code and lots should be returned as described in the Required Actions section below. If you have distributed the Argyle" Suction tubing lis |
| Quantity | 58,954 |
| Distribution | USA (nationwide) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.