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Terminated

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

FDA Recall Z-1431-06 · Posted 2006-08-24

Recalling FirmNellcor Puritan Bennett
Recall StatusTerminated
Product CodeBSR
Date Initiated2006-07-12
Date Terminated2007-01-10
Product Quantity30,366 cases of 20 units per case were distributed worldwide

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.

Firm 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.

Root Cause

Other

Distribution Pattern

The product has been distributed to 454 consignees throughout the United States, Guam and Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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