Stryker Sustainability Solutions Recall 85413
Description: 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
Stryker Sustainability Solutions Recall 85413 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2113-2020 |
| Event ID | 85413 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | US: AZ, CA, FL, GA, ID, IL, IN, KS, MA, MO, PA, TN, TX, VA, WA, WV OUS: None |
| Quantity | 101 units |
| Recall Reason | 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. |
| Device Classification | 20210203 |
| Device Code Info | 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 |
| Center Classification Date | 20210128 |
| Recall Initiation Date | 20200327 |
| Recalling Firm | Stryker Sustainability Solutions |
| Initial Notification | |
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