Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Cath

FDA device recall Z-0509-2024 · posted 2023-12-08 · Open, Classified

Recall details

Recalling firm

Spectranetics Corporation

Reason for recall

Incorrect product labeling. Exterior product box label does not match internal pouch label.

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.

Root cause

Packaging process control

Status

Open, Classified

Product code

MCW

Quantity affected

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 Dis

Date initiated

2023-11-15

Date posted

2023-12-08

Location

Colorado Springs, CO

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