Suction catheter kits recalled over a smaller catheter packed inside
Medline is recalling 141,971 of its 14 Fr Suction Catheter Kits because an 8 Fr catheter may have been packed in place of the required 14 Fr catheter.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the wrong catheter size may result in hypoxia or respiratory failure from airway obstruction, and no injuries are reported.
Plain-English summary
Medline 14 Fr Suction Catheter Kits, SKU DYND40972, a respiratory convenience kit, are being recalled by Medline Industries, LP.
The record states a smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. The record states use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction, that airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death, and that other potential outcomes include prolonged procedure, airway irritation or prolonged dyspnea.
The record lists 141,971 units under kit lot 48625040001, UDI 10080196033317 (each) and 40080196033318 (case). Distribution was nationwide in the US and Canada. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected kits and follow Medline's instructions, checking catheter size before use.
The recalled product
- Product
- Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Respiratory kit
- Affected units
- 141,971
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 (1)
- Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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