Reported Apr 17, 2013 · Terminated
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a…
Engineered Medical Systems,Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Engineered Medical Systems,Inc · 2055 Executive Drive · Indianapolis, IN · 46241-4311
Is this the product you have?
- 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. .
- Lot codes and dates
- REF 8-205508-00 Lot Number820550800110419
- Amount recalled
- 1500pcs, 75cs {20pcs per cases)
Where it was sold
Why it was recalled
Stop using this product now
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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