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Swann Morton Ltd.
SWANN-MORTON LIMITED · Model No. 19 STERILE DISPOSABLE SCALPELS · UDI-DI 05033955005245
10
510(k) clearances
127
Adverse events
6
Recalls
164
Facilities
Description
A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-11-06 | Southmedic, Inc. | Scalpels lot contains non-sterile products labeled as sterile. |
| 2015-08-18 | Zien Medical Technologies, Inc | Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause anal |
| 2013-02-07 | Myco Medical Supplies Inc | Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
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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.