Microcuff Endotracheal Tube; Pediatric Oral/Nasal Magill: ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30; ID Si
FDA device recall Z-1263-06 · posted 2006-07-25 · Terminated
Recall details
- Recalling firm
- Microcuff Gmbh
- Reason for recall
- Inadequate seals and/or holes in the pouch may compromise the sterility of the product.
- Action taken
- A notification by telephone was made in April 2006. A confirmation letter was later sent on 6/29/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 1730 units (total for all three types)
- Distribution
- U.S.
- Date initiated
- 2006-06-19
- Date posted
- 2006-07-25
- Date terminated
- 2007-05-01
- Location
- Weinheim, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES (K050803) | Vitaid, Ltd. | 2005-06-30 |