Teleflex Recalls LMA Supreme Size 5 Due to Potential Size 4 Mislabeling
Teleflex Medical is recalling 2,640 units of LMA Supreme (New Cuff) Size 5 devices because some may be mislabeled as Size 5 but are actually Size 4.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a labeling error (mislabeling) rather than a direct contamination or structural defect, and no injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling 2,640 units of LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, sterile, single-use devices. The recall is due to a labeling error where units from the affected lot are labeled as Size 5 but may actually contain Size 4 devices.
The affected devices are identified by Catalog No. 175050 and Lot no. HMAUGK. These devices were distributed worldwide, including in the United States (AZ, CA, DE, FL, GA, IL, KY, MO, NY, OK, PA, TX, VA, and WA) and Canada. The LMA Supreme is used to achieve and maintain control of the airway during routine anesthesia, cardiopulmonary resuscitation, and failed intubation situations.
Healthcare providers should stop using the affected devices and contact Teleflex Medical for instructions on return or replacement. Patients who have received these devices should consult their healthcare provider if they have concerns regarding the size of the airway device used.
The recalled product
- Product
- LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the faile
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 2,640
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 (2)
- Catalog No(s): 175050
- Lot no. HMAUGK
Distribution
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