Medtronic Ares Antibiotic-Impregnated Catheter recall: Sterility Concern
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system…
Why was Medtronic Ares Antibiotic-Impregnated Catheter 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 0010038455, 0010258429, 0010289822, 0010316971, 0010376783, 0010061294, 0010258430, 0010289823, 0010316972, 0010384872, 0010061295, 0010258433, 0010297674, 0010316973, 0010384874, 0010083617, 0010265129, 0010297675, 0010336621, 0010384881, 0010083618, 0010265130, 0010297676, 0010336622, 0010384888, 0010083619, 0010265131, 0010297683, 0010336623, 0010393228, 0010083620, 0010265133, 0010305904, 0010353498, EB00006085, 0010083622, 0010265134, 0010305905, 0010353499, EB00006086, 0010083623, 0010265135, 0010305906, 0010369357, EB00006166, 0010097240, 0010278428, 0010305907, 0010369358, EB00007496, 0010097241, 0010278430, 0010305908, 0010369359, EB00007537, 0010097249, 0010281382, 0010305909, 0010376779, EB00009476, 0010097250, 0010281383, 0010316967, 0010376781, 0010097251, 0010289819, 0010316968, 0010376782
- Product
- Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system…
- Recalling firm
- Medtronic Neurosurgery
- Quantity
- 3,858 units
- Distribution
- Worldwide Distribution. US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam
- Recall date
- January 6, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)