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KIT 101
APPLIED MEDICAL RESOURCES CORPORATION · Model K2291 · UDI-DI 30607915128969
10
510(k) clearances
42,565
Adverse events (126 deaths)
45
Recalls
107
Facilities
Description
Kit Contains: CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF12, 5x100 Kii® Fios® ADVFIX DP 10/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-04-28 | TELEFLEX LLC | Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of th |
| 2021-04-16 | Aesculap Implant Systems LLC | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery |
| 2021-04-16 | Aesculap Implant Systems LLC | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery |
| 2020-09-17 | Genicon, Inc. | Device malfunction causing the applier to jam, and clip loading failures. |
| 2019-11-07 | Ethicon Endo-Surgery Inc | A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility. |
| 2019-10-04 | Teleflex Medical | Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming |
| 2019-10-04 | Teleflex Medical | Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming |
| 2018-04-02 | AESDEX | Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components. |
| 2018-04-02 | AESDEX | Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components. |
| 2018-01-22 | Aesculap Implant Systems LLC | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for k |
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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.