—#128606

Product

Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

FDA product code: CCW — Laryngoscope, Rigid
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Product Code: 004434400, Lot number: 02A1402138

Why it was recalled

Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are incorrect, Miller 4 blades.

Root cause (FDA determination)

Other

Action the firm took

Teleflex Medical sent an Urgent Medical Device Recall Notification dated July 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- 804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: US Distribution including the states of FL, GA, KY, MD, MS, MT, PA, SC and TX.

Timeline

Recall initiated: 2014-07-09
Posted by FDA: 2014-07-26
Terminated: 2015-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128606. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.