Home › NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. › AED ETH1592-RN Romeo Needle Holder, 5mm x 33cm

AED ETH1592-RN Romeo Needle Holder, 5mm x 33cm

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Model ETH1592-RN · UDI-DI 00848657076043

FHQ Prescription

510(k) clearances

1,041

Adverse events

Recalls

346

Facilities

Description

A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle.

Recalls

Date	Firm	Reason
2020-06-26	Boss Instruments, Ltd.	The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
2020-06-03	Dufner Instrumente GmbH	Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury
2017-05-01	Cook Inc.	COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti
2009-07-30	Davol, Inc., Sub. C. R. Bard, Inc.	Product sterility may be compromised due to lack of package integrity.

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Data 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.