Recall Z-1144-2007 ยท BTR Tube, Tracheal (W/Wo Connector)
Kimberly-Clark Corporation
Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made in Malaysia
| Date | Aug 8, 2007 (initiated Jun 4, 2007) |
| Status | Terminated |
| Reason | The tubes may kink during use which may impede or prevent ventilation. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| 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 |