Medline Industries Recalls 14 Fr Suction Catheter Kits Due to Incorrect Component Sizing
Medline Industries, LP is recalling over 141,000 suction catheter kits because they may contain an undersized 8 Fr catheter, posing a risk of airway obstruction and respiratory failure.
What Happened
Medline Industries, LP has initiated a voluntary recall of its 14 Fr Suction Catheter Kits. The recall was prompted by the discovery that a smaller 8 Fr suction catheter may have been packaged within the kits instead of the required 14 Fr catheter. Using an incorrectly sized catheter can lead to partial or full airway obstruction, which may result in hypoxia, respiratory failure, or death.
Which Products Are Affected
The recall affects approximately 141,971 units distributed across the United States and Canada. The specific details for the affected products are as follows:
- Product Name: Medline 14 Fr Suction Catheter Kits (respiratory convenience kit)
- SKU: DYND40972
- Recall Number: Z-1312-2026
- Affected Lot: 48625040001
- UDI (Each): 10080196033317
- UDI (Case): 40080196033318
What You Should Do
Medline Industries notified customers of the issue via a formal letter. Healthcare providers and distributors should immediately check their inventory for the affected lot number (48625040001). If the affected product is found, it should be quarantined and handled according to the instructions provided in the firm’s notification. For further assistance, consumers may contact Medline Industries, LP at their headquarters in Northfield, Illinois.
Why This Matters
The use of an undersized catheter in a respiratory procedure is a significant safety concern. Airway obstruction caused by the incorrect component may require immediate emergent medical intervention to prevent life-threatening complications, including respiratory failure or death.
Source
This information is based on official recall data provided by the FDA.
Source: FDA Official Notice