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Scanlan® SURG-I-LOOP® PLUS with semi-sharp needle
SCANLAN INTERNATIONAL INC · Model 1001-82P · UDI-DI 00846159000313
GAE
Prescription
4
510(k) clearances
150
Adverse events
3
Recalls
67
Facilities
Description
Scanlan® SURG-I-LOOP® PLUS with semi-sharp needle - Light Orange, 37cm long, needle 1mm diam (2/pkg)
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. |
| 2008-05-09 | Bard Peripheral Vascular Inc | This action is being taken because the product has a potential for the handle to detach. The handle detachment may result in the device unable to retrieve the filter or foreign bod |
| 2008-05-09 | Bard Peripheral Vascular Inc | This action is being taken because the product has a potential for the handle to detach. The handle detachment may result in the device unable to retrieve the filter or foreign bod |
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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.