LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement o
FDA device recall Z-2022-2012 · posted 2012-07-17 · Terminated
Recall details
- Recalling firm
- LMA North America Inc
- Reason for recall
- The recall was initiated because LMANA has received a complaint that the Esophageal Intubation Detector (EID100) has a potential to create a false positive if used on a patient during confirmation of intubation.
- Action taken
- LMA North America Inc. sent a recall letter dated May 23, 2012, for US customers, and May 24, 2012, for International customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to fill out the bottom portion of the recall letter and promptly fax it back to LMA North America at (858) 622-4130. If customers have units of EID100 from the affected lots remaining in stock, customers were instructed to arrange for immediate return by contacting LMANA's customer service department at (800) 788-7999, menu selection #2. For further questions please contact Customer Service Representative at (800) 788-7999.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 18,799 units
- Distribution
- Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
- Date initiated
- 2012-05-23
- Date posted
- 2012-07-17
- Date terminated
- 2012-12-26
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ESOPHAGEAL INTUBATION DETECTOR (K930741) | Wolfe-Carney Medical | 1993-08-07 |