Recall Z-2145-2018 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Sun Med, LLC
STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
| Date | May 24, 2018 |
| Status | Terminated |
| Reason | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. |
| Root cause | Mixed-up of materials/components |
| Action | On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions: 1) Examine inventory, quarantine and cease distribution of impacted product. 2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed. 3) Complete and ret |
| Quantity | 76 cases |
| Distribution | IL & OH distributors |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953546 | MANUAL PULMONARY RESUSICITATOR Medical Marketing Concepts, Feb 29, 1996 |