Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
FDA device recall Z-1431-06 · posted 2006-08-24 · Terminated
Recall details
- Recalling firm
- Nellcor Puritan Bennett
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- BSR
- Quantity affected
- 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.
- Date initiated
- 2006-07-12
- Date posted
- 2006-08-24
- Date terminated
- 2007-01-10
- Location
- Pleasanton, CA
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