Recall Z-0509-2024
Spectranetics Corporation · initiated November 15, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152 The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.
Codes / lots: Model Number: 420-159 UDI code: 01)00813132024734(17)250614(10)FAZ23F06A Lot Number: FBH23F02A Model Number: 420-006 UDI code: (01)00813132024758(17)250622(10)FBA23F09A Lot Number: FBA23F09A Model Number: 414-159 UDI code: (01)00813132024727(17)250621(10)FBF23F05B Lot Number: FBF23F05B Model Number: 417-152 UDI code: (01)00813132024765(17)250623(10)FBH23F02A Lot Number: FAZ23F06A
Reason for recall
Incorrect product labeling. Exterior product box label does not match internal pouch label.
FDA-determined cause: Packaging process control
Action taken
On 11/15/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via US Postal Service Certified Mail to customers informing them that as a result of 3 complaints received the firm became aware that exterior box labels were incorrectly labeled and did not match the interior product pouch label. Customers are instructed to: -Immediately check their product inventory and quarantine any potentially affected devices from the affected lots. -Do not open or use any products that have been identified with their inventory -Complete and return the Response Form within 30 days so that Philips can initiate the return and replacement process free of charge (based upon the completed Response Form) -Circulate the notice to all users and/or to any organization where the potentially affected devices may have been transferred -Send completed Response Forms via email to igtdc.r@philips.com For questions or further assistance, contact local Philips representative or Philips Image Guided Therapy Devices Customer Service at 1-800-231-0978, option 2.
Details
- Recall number
- Z-0509-2024
- Initiated
- November 15, 2023
- Posted by FDA
- December 8, 2023
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Quantity
- 1,239 catheters
- Distribution
- U.S Nationwide - Worldwide Distribution: US Distribution: AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, and WA Foreign Distribution: Germany, Italy, Poland and Spain
- Recalling firm
- Spectranetics Corporation, Colorado Springs, CO