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AVAflex
CAREFUSION 2200, INC · Model AFB1015 · UDI-DI 10885403223259
NDN
Prescription
10
510(k) clearances
4,809
Adverse events (94 deaths)
86
Recalls
114
Facilities
Description
AVAFLEX™ VERTEBRAL BALLOON SYSTEM 10GX15MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-15 | TEKNIMED SAS | Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28. |
| 2021-05-18 | Stryker Spine | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. |
| 2021-05-18 | Stryker Spine | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.