Reported Jul 8, 2015 · Terminated
Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus…
Alcon Research, Ltd.
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: Alcon Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
8065741018 | Accurus 2500 Standalone Vitreous Probe |
8065750821 | Accurus 23 GA Standalone Vitreous Probe |
8065751122 | Accurus 25+ 2500 CPM Standalone Vitreous Probe |
8065803650 | Anterior Accurus Probe with Infusion Needle |
| — | Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console. |
- Lot codes and dates
44 of 44 products
Products covered by this recall # Product as published 1 Lot Number: 14010428X, Expiration Date: 1/14/2017 2 Lot Number: 14012987X, Expiration Date: 2/17/2017 3 Lot Number: 14014736X, Expiration Date: 3/11/2017 4 Lot Number: 14016577X, Expiration Date: 3/26/2017 5 Lot Number: 14017912X, Expiration Date: 4/27/2017 6 Lot Number: 14020280X, Expiration Date: 5/21/2017 7 Lot Number: 14022920X, Expiration Date: 6/19/2017 8 Lot Number: 14024168X, Expiration Date: 6/22/2017 9 Lot Number: 14026031X, Expiration Date: 7/27/2017 10 Lot Number: 14028553X, Expiration Date: 8/12/2017 11 Lot Number: 14029477X, Expiration Date: 8/26/2017 12 Lot Number: 14033830X, Expiration Date: 10/14/2017 13 Lot Number: 14036315X, Expiration Date: 11/17/2017 14 Accurus 25+ 2500 CPM Stand-Alone Vitreous Probe: Lot Number: 14010429X, Expiration Date: 1/14/2014 15 Lot Number: 14012985X, Expiration Date: 2/17/2017 16 Lot Number: 14014737X Expiration Date: 3/11/2017 17 Lot Number: 14016477X Expiration Date: 3/26/2017 18 Lot Number: 14018320X Expiration Date: 4/27/2017 19 Lot Number: 14020282X Expiration Date: 5/21/2017 20 Lot Number: 14022922X Expiration Date: 6/19/2017 - Amount recalled
- 35,475 units
Where it was sold
- Nationwide
Why it was recalled
Insufficient seal on the outside packaging, potentially affecting the sterility of the product.
This product could cause temporary or reversible health problems — stop using it.
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