Class 2 Device Recall Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter

• Date Initiated by Firm: March 27, 2020
• Date Posted: June 01, 2020
• Recall Status: Terminated on October 14, 2022
• Recall Number: Z-2113-2020
• Recall Event ID: 85413
• 510(K)Number: K182238
• Product Classification: Reprocessed intravascular ultrasound catheter - Product Code OWQ
• Product: Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
• Code Information: 2197475 2235448 2235454 2243623 2261903 2264435 2264468 2264478 2264484 2039314 2079692 2120924 2121216 2264953 2264955 2264983 2272787 2275104 2073119 2080853 2081724 2081992 2081993 2082097 2611753 2652454 2663966 2663971 2663956 2663959 2663973 2663997 2663999 2664000 2664027 2664028 2664038 2664039 2664041 2664042 2664054 2649640 2649643 2652050 2652100 2652106 2652108 2652123 2652127 2652128 2652130 2652131 2652175 2663895 2663904 2663905 2663907 2663909 2663929 2652008 2652010 2652011 2652080 2652084 2652085 2652090 2652097 2656413 2656414 2656415 2656421 2656442 2656443 2656444 2656448 2656449 2656450 2656458 2656462 2656463 2656474 2656475 2656479 2656485 2656488 2449500 2449504 2449584 2456071 2456077 2456078 2456593 2456604 2456605 2456607 2456609 2456610 2456620 2447265 2459137 2459155
• Recalling Firm/ Manufacturer: Stryker Sustainability Solutions; 1810 W Drake Dr; Tempe AZ 85283-4327
• For Additional Information Contact: Marissa Richmond; 888-888-3433
• Manufacturer Reason for Recall: A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.
• FDA Determined Cause: Labeling False and Misleading
• Action: The firm will execute the recall in four phases: 1) Provide the Urgent Medical Device Recall Customer Notification Letter and Recall Business Reply Form to sales representatives via UPS on 3/27/2020 to notify affected customers; 2) Send the Urgent Medical Device Recall Customer Notification Letter and Recall Business Reply Form directly to affected customers; 3) Follow up phone calls and/or emails to nonrespondent customers as needed; 4) Additional follow up attempts to non-respondent customers as needed. The Urgent Medical Device Recall Customer Notification Letter and Recall Business Reply Form, dated March 2, 2020 instructs customers the following: The following Customer Actions are communicated in the Urgent Medical Device Recall Customer Notification Letter: Affected products may continue to be used prior to the one-year shelf life expiration. All products used prior to May 2020 are within the validated shelf life. 1. Please check your inventory for the affected devices. Affected devices may be identified through Serial Number (see Attachments 1 and 2). 2. Please complete the Urgent Medical Device Recall Business Reply Form (page 5) and indicate if any of the affected product remains in your inventory. Please return this completed form through one of the following methods: a. Email: SSSPFA@stryker.com b. To your Stryker Sustainability Solutions Sales Representative c. Fax: 480-763-5345 All faxes sent to 480-763-5345 will redirect to the SSSPFA@stryker.com email inbox. This email inbox will be monitored and customer responses will be documented to determine which customers have responded to the recall notification This form must be completed and returned to Stryker even if no affected product is found. 3. If any of the affected devices have been forwarded to additional facilities, please contact these facilities and communicate this recall to them. 4. Maintain awareness of this communication internally until all required ac
• Quantity in Commerce: 101 units
• Distribution: US: AZ, CA, FL, GA, ID, IL, IN, KS, MA, MO, PA, TN, TX, VA, WA, WV OUS: None
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OWQ and Original Applicant = Stryker Sustainability Solutions