Respironics Infant Masks Recalled Due to Incorrect Size Labeling
Engineered Medical Systems is recalling Respironics SealFlex Single Port Ribbed Masks labeled as Infant but actually Neonatal size.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of at least 4 according to the rubric, as it involves a reasonable probability of serious adverse health consequences.
Plain-English summary
Engineered Medical Systems, Inc. is recalling 1,500 units of the Respironics SealFlex Single Port Ribbed Mask (Infant). The recall was initiated because the masks inside the packages were identified as "Neonatal" in size, which does not match the "Infant" size indicated on the labeling.
The affected products are used in respiratory and anesthesia applications to resuscitate or enhance breathing abilities. The specific lot number is 820550800110419, and the reference number is 8-205508-00. The products were distributed in Pennsylvania, Indiana, New York, Colorado, and California.
Healthcare facilities and consumers should stop using these masks and contact the recalling firm for instructions on return or replacement. This recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
- Manufacturer
- Engineered Medical Systems,Inc
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)
- REF 8-205508-00 Lot Number: 820550800110419.
Distribution
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