LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization… recallZ-3212-2017 · Teleflex Medical · initiated Jul 5, 2017
Class II Terminated All recalls posted in August 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
FDA root cause category: Process control
What the company is doing
Teleflex sent an Urgent Medical Device Recall Notification letter on July 5, 2017, to all affected customers. The letter directed the following actions: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. 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 products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter." For questions regarding this recall call 866-246-6990.
Recall details
- Recall number
- Z-3212-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 5, 2017
- Posted by the FDA
- Aug 25, 2017
- Recalling firm
- Teleflex Medical
- Quantity
- 135,456 units
- Product code
- CCT
- FDA submissions
- K153470
- Distribution
- Nationwide distribution
Product description
LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region
Code information (models, lots, serial numbers)
Lot Numbers: (a) MAD600 MADgic: 161217, 161218, 161228 (b) MAD700 MADgic: 161119, 161120, 161121, 161153, 161173, 161212, 161223, 161236 (c) MAD720 MADgic: 161154
Other devices under the same FDA submission
2 devices cleared under K153470 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LMA ATOMIZATION IPN915310Teleflex Incorporated · APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA2 reports
- LMA ATOMIZATION IPN048838Teleflex Incorporated · APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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