Recall Z-1058-2013
Engineered Medical Systems,Inc · initiated September 12, 2011
Class I – dangerous or defective products that could cause serious health problems or death
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. .
Codes / lots: REF 8-205508-00 Lot Number: 820550800110419.
Reason for recall
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
FDA-determined cause: Process change control
Action taken
Consignees were notified 9/12/2011 with a Medical Device Voluntary Recall letter identifying the product and the problem. Consignees were directed to quarantine, cease further distribution, and destroy the affected product, returning a proof of confirmation/disposal letter, to be submitted for credit. Correspondence should be sent to Tamara Lefevers, Quality Manager, at tlefevers@ engmedsys.com or fax 317-246-5501.
Details
- Recall number
- Z-1058-2013
- Initiated
- September 12, 2011
- Posted by FDA
- April 10, 2013
- Terminated
- August 2, 2013
- Product code
- BSJ – Mask, Gas, Anesthetic
- Quantity
- 1500pcs, 75cs {20pcs per cases)
- Distribution
- Distributed in the states of PA, IN, NY, CO, and CA.
- Recalling firm
- Engineered Medical Systems,Inc, Indianapolis, IN