Recall Z-1058-2013 ยท BSJ Mask, Gas, Anesthetic
Engineered Medical Systems,Inc
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. .
| Date | Apr 10, 2013 (initiated Sep 12, 2011) |
| Status | Terminated |
| Reason | The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 1500pcs, 75cs {20pcs per cases) |
| Distribution | Distributed in the states of PA, IN, NY, CO, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874746 | SEALFLEX MASK Engineered Medical Systems, Dec 21, 1987 |