Recall Z-2587-2017 ยท BSR Stylet, Tracheal Tube
Teleflex Medical
Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coated with a blue PVC or polypropylene outer covering and are designed to be placed inside an endotracheal tube to obtain a desired shape during intubation.
| Date | May 11, 2017 |
| Status | Open, Classified |
| Reason | Product size listed on the labeling is incorrect. |
| Root cause | Labeling mix-ups |
| Action | Recall letters were sent to consignees on 5/11/2017 asking them to check inventory and immediately discontinue use of the product. The letter included a reply form to be returned. A separate letter was sent to distributors requesting that they conduct a sub-recall. |
| Quantity | 21,690 eaches |
| Distribution | Worldwide Distribution - US Nationwide in the states of CT, FL, ID, IN, KY, MA, MI, MN, MO, NE, NJ, NY, NC, OH, PA, RI, SD, TX, UT, WA and countries of Canada, Czech Republic, Denmark, Germany, Israel, & Portugal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.