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A.C.S® (Alcon Closure System)
Alcon Laboratories, Inc. · Model 8065213201 · UDI-DI 00380652132015
GAS
Prescription
10
510(k) clearances
825
Adverse events (9 deaths)
1
Recalls
43
Facilities
Description
Suture - Needle Type R-3,Green Braided Polyester(GBP), Suture Size 5-0, Suture Length 18,Double Armed
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
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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.