Flexi Nozzle Short recallZ-0383-2017 · Teleflex Medical · initiated Oct 27, 2016

Why it was recalled

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

FDA root cause category: Process control

What the company is doing

Teleflex sent an Urgent Medical Device Recall Notification letter on/about October 27, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine affected products. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax it to Teleflex Customer Service or email to [email protected]. For questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990. Teleflex sent an Amended Urgent Medical Device Recall Notification letter dated November 22, 2016, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to continue to return affected product for a full refund per the procedure set forth in the letter of October 27, 2016. Some customers have indicated that, due to medical necessity, they plan to continue using the affected lots rather than return them. Teleflex is advising all such customers to follow the supplemental instructions for Use included as Attachment B. These supplemental instructions allow non-destructive testing of each unit prior to the procedure to determine if it is defective. Institutions that intend to continue using affected lots with this supplemental testing, please send the acknowledgment form to [email protected] with their name and contact information and the lots that they will continue to use, or call 866-246-6990. Customers with questions should contact their local sales representative or Customer Service at 1-866-246-6990.

Recall details

Recall number

Z-0383-2017

Recall class

Class II

Status

Terminated

Initiated by the company

Oct 27, 2016

Posted by the FDA

Nov 9, 2016

Recalling firm

Teleflex Medical

Quantity

2,674,650 units in total

Product code

CCQ

FDA submissions

K153470

Distribution

Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.

Product description

FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

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 IPN915310

  Teleflex Incorporated · APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA
  2 reports
• LMA ATOMIZATION IPN048838

  Teleflex Incorporated · APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 75554).

• Z-0384-2017 · Terminated
  LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, …