Recall Z-2022-2012 ยท BTR Tube, Tracheal (W/Wo Connector)
LMA North America Inc
LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment
| Date | Jul 17, 2012 (initiated May 23, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. F |
| Quantity | 18,799 units |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930741 | ESOPHAGEAL INTUBATION DETECTOR Wolfe-Carney Medical, Aug 7, 1993 |