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WIDE-EYE Multitrap

BODDINGTONS PLASTICS LIMITED · Model APT006 · UDI-DI 05060423410393

NNI Prescription
0
510(k) clearances
29
Adverse events
4
Recalls
330
Facilities

Description

The Arc WIDE-EYE Multi Trap family of devices is designed to attach to the suction port of an endoscope and capture excised material by applying suction through the biopsy channel of the endoscope. This device is a specimen transport container.

Recalls

DateFirmReason
2026-03-09Milestone S.R.L.There is a possibility of reagent leakage from the specimen container.
2021-12-01MEDLINE INDUSTRIES, LP - NorthfieldProduct stored incorrectly in temperature controlled setting instead of refrigeration.
2016-03-03Dynarex CorporationExterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
2011-02-18Cardinal Health IncIn one lot of product (lot# 1091745), the label for the small version of the sock (catalog number 65652-123) was improperly used for the larger version of the product (65652-124)

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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.