Home › Avalign Technologies, Inc. › Millennium
Millennium
Avalign Technologies, Inc. · Model 85-72049128 · UDI-DI 00190776359775
HMX
Prescription
10
510(k) clearances
801
Adverse events
28
Recalls
236
Facilities
Description
Simcoe Capsule Scrubber,
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-06 | Iantrek Inc. | Potential for compromised integrity of the sterile packaging. |
| 2024-02-02 | Beaver Visitec International, Inc. | Pack and pouch label is missing the manufacturing and expiration date. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2021-04-21 | Anodyne Surgical | The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula. |
| 2021-02-25 | Dutch Ophthalmic USA, Inc. | Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281 |
| 2019-12-17 | Vitreq Bv | Microscopic tears of the sterile pouch may compromise sterility |
| 2019-12-17 | Vitreq Bv | Microscopic tears of the sterile pouch may compromise sterility |
| 2019-12-17 | Vitreq Bv | Microscopic tears of the sterile pouch may compromise sterility |
| 2019-12-17 | Vitreq Bv | Microscopic tears of the sterile pouch may compromise sterility |
| 2019-12-17 | Vitreq Bv | Microscopic tears of the sterile pouch may compromise sterility |
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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.