Recall Z-1263-06 ยท BTR Tube, Tracheal (W/Wo Connector)
Microcuff Gmbh
Microcuff Endotracheal Tube; Pediatric Oral/Nasal Magill: ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product Reference: I-MPEDC-35; ID Size: 4,0mm, Product Reference: I-MPEDC-40; ID Size: 4.5mm, Product Reference: I-MPEDC-45; ID Size: 5,0mm, Product Reference: I-MPEDC-50; ID Size: 5,5mm, Product Reference: I-MPEDC-55; ID Size: 6,0mm, Product Reference: I-MPEDC-
| Date | Jul 25, 2006 (initiated Jun 19, 2006) |
| Status | Terminated |
| Reason | Inadequate seals and/or holes in the pouch may compromise the sterility of the product. |
| Root cause | Other |
| Action | A notification by telephone was made in April 2006. A confirmation letter was later sent on 6/29/2006. |
| Quantity | 1730 units (total for all three types) |
| Distribution | U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050803 | PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES Vitaid, Ltd., Jun 30, 2005 |