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gSource
GSOURCE LLC · Model gS 42.5940 · UDI-DI 00840314220103
10
510(k) clearances
277
Adverse events
7
Recalls
313
Facilities
Description
Johnson-Tucker Hook and Fork 6 1/2"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-11-12 | MEDLINE INDUSTRIES, LP - Northfield | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2011-12-06 | Teleflex Medical | Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there |
| 2011-12-06 | Teleflex Medical | Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there |
| 2008-05-12 | Telefelx Medical | The bands are breaking within the sealed packaging or in use prior to the expiration dates. |
| 2008-05-12 | Telefelx Medical | The bands are breaking within the sealed packaging or in use prior to the expiration dates. |
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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.