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.
Recall
- Recall Number
- Z-2587-2017
- Event Number
- 77330
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- BSR
- Status
- Open, Classified
- Root Cause
- Labeling mix-ups
- Initiated
- May 11, 2017
- Address
- 2917 Weck Dr, Research Triangle Park, NC, 27709-0186
Description
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.
Product size listed on the labeling is incorrect.
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.
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
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