FDA Medical Device Recalls (openFDA)
Nellcor Puritan Bennett: Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
- Recall number
- Z-1431-06
- Recalling firm
- Nellcor Puritan Bennett
- Product
- Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
- Status
- Terminated
- Initiated
- 2006-07-12
- Posted
- 2006-08-24
- Terminated
- 2007-01-10
- Reason
- Product's outer sheath material may separate from the wire interior during use and may lodge in the endotracheal tube or enter the patient's airway and interfere with ventilation.
- Root cause
- Other
- Action
- The firm has issued notification letters via USPS certified mail with return receipt, requesting that the recipients who have further distributed the product forward a copy of that letter. The firm intends to contact non-responding companies beginning 30 days after the initial notification is sent.
- Quantity
- 30,366 cases of 20 units per case were distributed worldwide
- Distribution
- The product has been distributed to 454 consignees throughout the United States, Guam and Japan.
- Lot, serial or model codes
- Model number 85863 (size 6 French), all lot codes beginning in 05 and 06
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSR
- Firm FEI
- 2936999
- Firm city
- Pleasanton
- Firm state
- CA
- 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