Reported Jan 6, 2021 · Ongoing
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as…
Medtronic Neurosurgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neurosurgery · 5290 California Ave · Irvine, CA · 92617-3073
Is this the product you have?
- Medtronic Ares Antibiotic-Impregnated Catheter
- REF91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated
- Lot codes and dates
- Lot Numbers
001005254900102898290010305920001035350100103848930010052552001028983000103059210010353502001038489400101490110010289831001030592300103535030010384895001014901300102898330010305926001035350400103848960010258434001028983400103169550010369362001039321300102651360010297686001031695600103693640010393215001026513700102976890010316957001036936500103932160010265138001029769100103169580010376787001039381400102784080010297693001033661700103767880010393839001027840900102976960010336618001037678900102898270010305912001033661900103767900010289828001030591900103535000010384892
- Lot Numbers
- Amount recalled
- 3,165 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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