—#171517

Product

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

FDA product code: BTO — Tube, Tracheostomy (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K030381
Affected lot / code info: Item code/product number: 100/856/080 lot number: 3578884

Why it was recalled

Packaged with an incorrect size inner cannula.

Root cause (FDA determination)

Error in labeling

Action the firm took

During the week of February 11, 2019, the firm sent URGENT MEDICAL DEVICE FIELD SAFETY NOTICE emails to their consignees advising them to check their stock, complete an enclosed. INSTRUCTIONS TO CUSTOMERS: 1.Locate and determine the number of affected products in your possession. (Product Number: 100/856/080 Lot Number: 3578884) 2.Complete the attached Response Form within 10 days and return it to fieldactions@smiths-medical.com, even if you do not have any of the affected product in your possession. 3.Return affected product to Stericycle utilizing the pre-paid shipping labels included with this notice. Include a copy of your completed Response Form inside EACH BOX of returned product to facilitate processing of credit. Ensure boxes are sealed and labeled with your facility name prior to shipping. 4.DISTRIBUTORS: If you have distributed potentially affected devices to your customers, please immediately notify them of this Field Safety Corrective Action. Smiths Medical is committed to providing quality products and service to its customers. We apologize for any inconvenience this situation may cause. If you have any questions regarding this notification, please contact Smiths Medical via email at fieldactions@smiths-medical.com. FIELD SAFETY NOTICE RESPONSE FORM and return an affected devices to Stericycle. The emails also instructed distributors to conduct a subrecall.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland

Timeline

Recall initiated: 2019-02-11
Terminated: 2020-11-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171517. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.