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WECK
TELEFLEX INCORPORATED · Model IPN028283 · UDI-DI 34026704621508
GDO
Prescription
10
510(k) clearances
16,547
Adverse events (40 deaths)
8
Recalls
150
Facilities
Description
HORIZON APPLIER SMALL 6" CURVED REFURBISHED
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-08-24 | Teleflex Medical | Misbranded: Incorrect etching on the device. |
| 2015-11-02 | The Anspach Effort, Inc. | Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498). |
| 2013-04-12 | Ethicon Endo-Surgery Inc | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues whi |
| 2013-04-12 | Ethicon Endo-Surgery Inc | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues whi |
| 2013-04-12 | Ethicon Endo-Surgery Inc | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues whi |
| 2004-06-07 | Ethicon Endo-Surgery | This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubula |
| 2003-05-21 | Weck | Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment. |
| 2001-10-31 | Weck | The flush port on some appliers was occluded with an epoxy resin during manufacturing. |
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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.