Z-0366-2014Class II
Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement...
Teleflex Medical / initiated 2013-10-15 / Terminated / root cause: labeling and UDI
Teleflex Medical began a recall of Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube on . FDA classified it as Class II and gives the reason as "Labeling inconsistency". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0366-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Teleflex Medical
- Product
- Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.
- Product code
- CCW Laryngoscope, Rigid
- Reason for recall
- Labeling inconsistency
- Root cause tag
- labeling and UDI
- FDA root cause
- Other
- Action
- Recall letters were sent to customers and distributors on 10/15/2013 via courier. The letter indicated that the consignee was to immediately discontinue use and quarantine any products with the affected catalog numbers. The letter also included a Recall Acknowledgment Form which was to be faxed back to the firm.
- Quantity in commerce
- 6,200 ea.
- Distribution
- Nationwide distribution: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WI.
- Product codes and lots
- Product Code 004551004; Lot 1305342
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0366-2014 | Class II | Terminated | Voluntary: Firm initiated |
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