Respironics SealFlex Single Port Ribbed Mask recall: Labeling Error
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to…
Why was Respironics SealFlex Single Port Ribbed Mask recalled?
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF 8-205508-00 Lot Number: 820550800110419.
- Product
- Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to…
- Recalling firm
- Engineered Medical Systems,Inc
- Quantity
- 1500pcs, 75cs {20pcs per cases)
- Distribution
- Distributed in the states of PA, IN, NY, CO, and CA.
- Recall date
- April 17, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)