FDA Recall
Terminated
BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation.
Recall: Z-1488-2012
·
Initiated December 8, 2010
Recall
- Recall Number
- Z-1488-2012
- Event Number
- 61464
- Firm
- Bomimed Inc 96 Terracon Pl Winnipeg Canada Manitoba
- FEI Number
- 3005396516
- Product Code
- EQN
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- December 8, 2010
- Posted
- May 3, 2012
- Terminated
- May 8, 2012
Description
BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation.
Reason
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.
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.
Distribution
US Distribution to the state of California.
Quantity
30 units