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Swann Morton Ltd.
SWANN-MORTON LIMITED · Model No. 22A NON STERILE BLADES · UDI-DI 05033955001094
10
510(k) clearances
970
Adverse events
13
Recalls
304
Facilities
Description
Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be attached to the scalpel handle. It is capable of cutting through tissue when moved with downward pressure. This device is disposable.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-27 | Southmedic, Inc. | Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold |
| 2016-06-27 | Aspen Surgical Puerto Rico Corp. | After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil |
| 2012-08-15 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | Potential for bent tips. |
| 2012-08-15 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | Potential for bent tips. |
| 2012-08-15 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | Potential for bent tips. |
| 2012-08-15 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | Potential for bent tips. |
| 2009-09-29 | Merit Medical Systems, Inc. | Potential sterility breach caused by excessive shipment damage. |
| 2008-11-17 | Miltex, Inc. | Blade may break: Over milling of the blade resulted in tip more narrow than specified. |
| 2007-08-10 | Becton Dickinson & Company | Complaints received of rust on the blades of BD Bard-Parker Surgical blades. |
| 2007-08-10 | Becton Dickinson & Company | Complaints received of rust on the blades of BD Bard-Parker Surgical blades. |
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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.