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Terminated

BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation.

FDA Recall Z-1488-2012 · Posted 2012-05-03

Recalling FirmBomimed Inc
Recall StatusTerminated
Product CodeEQN
Date Initiated2010-12-08
Date Terminated2012-05-08
Product Quantity30 units

Reason for Recall

On 9/1/2010 BOMImed, Inc. Winnipeg, MB, Canada initiated a recall of their BOMImed Integrated Reusable Laryngoscope Blades (Macintosh & Miller styles - all sizes), Model #OL-32D0 to OL-32D4 & OL-32E00, OL-32E0, OL-32E1, OL-32E2, OL-32E3, OL-32E4.

Firm Action

BOMImed sent a "Medical Device Safety Alert & Correction Action" letter by Fax and Mail on 11/25/2010 to the consignee. The product issue was described and recommended actions to mitigate risk were provided. Contact number is 1-800-667-6276 ext. 234.

Root Cause

Process design

Distribution Pattern

US Distribution to the state of California.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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