Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a c
FDA device recall Z-1058-2013 · posted 2013-04-10 · Terminated
Recall details
- Recalling firm
- Engineered Medical Systems,Inc
- Reason for recall
- The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- BSJ
- Quantity affected
- 1500pcs, 75cs {20pcs per cases)
- Distribution
- Distributed in the states of PA, IN, NY, CO, and CA.
- Date initiated
- 2011-09-12
- Date posted
- 2013-04-10
- Date terminated
- 2013-08-02
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEALFLEX MASK (K874746) | Engineered Medical Systems | 1987-12-21 |