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
This recall has been terminated (originally issued August 8, 2007).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- June 4, 2007
- Posted
- August 8, 2007
- Terminated
- June 12, 2008
- Recall Number
- Z-1144-2007
- Quantity
- 4376 cases (43760 units/total for both products)
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The tubes may kink during use which may impede or prevent ventilation.
Distribution
Worldwide, including USA, Canada, Europe, Australia, Chile, Hong Kong, Singapore, Thailand, India, Malaysia and Saudi Arabia.
Lot / Code Info
Product code: 35162-07, 35162-07, 35163-07 and 35164-07, All lot numbers
Root Cause
Other
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.