Reported Jan 6, 2021 · Ongoing
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, 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
- REF95001, 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
68 of 68 codes
0010038455001025842900102898220010316971001037678300100612940010258430001028982300103169720010384872001006129500102584330010297674001031697300103848740010083617001026512900102976750010336621001038488100100836180010265130001029767600103366220010384888001008361900102651310010297683001033662300103932280010083620001026513300103059040010353498EB000060850010083622001026513400103059050010353499EB000060860010083623001026513500103059060010369357EB000061660010097240001027842800103059070010369358EB000074960010097241001027843000103059080010369359EB000075370010097249001028138200103059090010376779EB00009476
- Lot Numbers
- Amount recalled
- 3,858 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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