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Class 2 Device Recall Sheridan SHERISLIP and SOFTTIP Intubating Stylets |
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Date Initiated by Firm |
May 11, 2017 |
Create Date |
June 14, 2017 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2587-2017 |
Recall Event ID |
77330 |
Product Classification |
Stylet, tracheal tube - Product Code BSR
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Product |
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. |
Code Information |
Product Code 5-15103 - Lot Number 73J1600218, 73K1600376, 73K1600587, 73L1600158, 73M1600275, 73A1700733; |
Recalling Firm/ Manufacturer |
Teleflex Medical 2917 Weck Dr Research Triangle Park NC 27709-0186
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For Additional Information Contact |
Elizabeth Norwood 919-544-8000
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Manufacturer Reason for Recall |
Product size listed on the labeling is incorrect.
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FDA Determined Cause 2 |
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 in Commerce |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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