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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2587-2017 | Class II | Ongoing | Voluntary: Firm initiated |
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