Cardinal Health Recalls Lubricated Intubating Stylets Due to Shear Risk
Cardinal Health is recalling 104,432 Lubricated Intubating Stylets 6FR because a small piece of the sheath may shear off during removal, posing a risk to infants and pediatric patients.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential foreign object in the airway of vulnerable pediatric patients, which constitutes a significant injury risk, aligning with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Cardinal Health is recalling 104,432 units of Lubricated Intubating Stylets 6FR. These medical devices are inserted into endotracheal tubes to facilitate intubation and are primarily used on infants and pediatric patients in surgical or medical emergency facilities.
The recall was initiated because a small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube. This defect could result in a foreign object remaining in the patient's airway.
The affected products were distributed nationwide across the United States, including the District of Columbia, Guam, and a US Army facility in South Korea. Healthcare facilities should stop using the affected stylets and contact Cardinal Health for further instructions.
The recalled product
- Product
- Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.
- Manufacturer
- Cardinal Health
- Affected units
- 104,432
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Material Number: ISL6
- Lot Numbers: 1409LS45A-SH
- 1408LS41A-SH
- 1406LS22A-SH
- 1404LS14A-SH
- 1310LS23A-SH
- 1310LS21A-SH
- 1308LS17A-SH
- 1307LS14A-SH
- 1303LS04A-SH
- 1204LS03A-SH
- 1110LS10A-SH
- 1111LS11A-SH
- 1107LS07A-SH
- 1106LS06A-SH
- 1104LS04A-SH
- 1105LS05A-SH
- 1003020386-SH
- 912022138-SH
- 910021815-SH
Distribution
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