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U.S. Department of Health and Human Services

Class 2 Device Recall BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades

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  Class 2 Device Recall BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades see related information
Date Initiated by Firm December 08, 2010
Date Posted May 03, 2012
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-1488-2012
Recall Event ID 61464
Product Classification Laryngoscope, nasopharyngoscope - Product Code EQN
Product BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation.
Code Information Lot Numbers 0310, 0510, 2710, 3210, 4010 & 4510
Recalling Firm/
Manufacturer		 Bomimed Inc
96 Terracon Pl
Winnipeg Canada Manitoba
For Additional Information Contact Trina Friesen
204-633-2664 Ext. 234
Manufacturer 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.
FDA Determined
Cause 2		 Process design
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.
Quantity in Commerce 30 units
Distribution US Distribution to the state of California.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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