Z-1431-06

Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20

Name: Z-1431-06 Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
Creator: Nellcor Puritan Bennett
Published: 2006-07-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-07-12 / Terminated

FDA source

Nellcor Puritan Bennett began a recall of Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20 on 2006-07-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1431-06
Status: Terminated
Initiated: 2006-07-12
Posted: 2006-08-24
Terminated: 2007-01-10
Recalling firm: Medtronic, Inc.
Product: Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
Product code: BSR Stylet, Tracheal Tube
Reason for recall: 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.
FDA 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 in commerce: 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.
Product codes and lots: Model number 85863 (size 6 French), all lot codes beginning in 05 and 06

Product code BSR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)