FDA Medical Device Recalls (openFDA)
Kimberly-Clark Corporation: Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, 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
- Recall number
- Z-1143-2007
- Recalling firm
- Kimberly-Clark Corporation
- Product
- Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, 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
- Status
- Terminated
- Initiated
- 2007-06-04
- Posted
- 2007-08-08
- Terminated
- 2008-06-12
- 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.
- Lot, serial or model codes
- Product code 35111-07, 35112-07, 35113-07 and 35114-07, All Lots.
- 510(k) numbers
- ["K050803"]
- PMA numbers
- not on file
- Product code
- BTR
- Firm FEI
- 1000015879
- Firm city
- Roswell
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28