Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, sizes 3.0mm, 3.5mm, 4.0mm, and 4.5mm, Rx Only,
FDA device recall Z-1143-2007 · posted 2007-08-08 · Terminated
Recall details
- Recalling firm
- Kimberly-Clark Corporation
- Reason for recall
- The tubes may kink during use which may impede or prevent ventilation.
- Action taken
- Consignees were notified by letter sent via overnight mail on/about June 4, 2007. A follow-up letter was sent to consignees via fax on June 5, 2007. Consignees were instructed to cease distributing the product and return all affected product in inventory to Kimberly-Clark. Distributors were instructed to notify their accounts of the recall. A Product Recall Response Sheet (Packing Slip) was attached to the recall notice.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 4376 cases (43760 units/total for both products)
- Distribution
- Worldwide, including USA, Canada, Europe, Australia, Chile, Hong Kong, Singapore, Thailand, India, Malaysia and Saudi Arabia.
- Date initiated
- 2007-06-04
- Date posted
- 2007-08-08
- Date terminated
- 2008-06-12
- Location
- Roswell, GA
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 |