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DemeCRYL
Demetech Corporation · Model G184012B4P · UDI-DI 10652927302575
GAM
Prescription
1
510(k) clearances
56,265
Adverse events (88 deaths)
130
Recalls
144
Facilities
Description
Synthetic (polyglactin 910) , Absorbable Suture
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v |
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v |
| 2024-09-25 | Ethicon, Inc. | Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the pack |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-03-26 | SURGICAL SPECIALTIES | Complaints have been received with allegations of Incorrect Needle Curvature. |
| 2024-03-08 | Ethicon, Inc. | Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility |
| 2022-09-28 | Covidien, LP | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the ne |
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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.