Medical Device
Manufacturing
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Z-2587-2017Class II

Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized...

Teleflex Medical / initiated 2017-05-11 / Open, Classified / root cause: labeling and UDI

Teleflex Medical began a recall of 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... on . FDA classified it as Class II and gives the reason as "Product size listed on the labeling is incorrect". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2587-2017
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Teleflex Medical
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.
Product code
BSR Stylet, Tracheal Tube
Reason for recall
Product size listed on the labeling is incorrect.
Root cause tag
labeling and UDI
FDA 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 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
Product codes and lots
Product Code 5-15103 - Lot Number 73J1600218, 73K1600376, 73K1600587, 73L1600158, 73M1600275, 73A1700733;

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2587-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2587-2017Class IIOngoingVoluntary: Firm initiated