Recall Z-1938-2015 ยท PAD Chest Drainage Kit
Atrium Medical Corporation
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
| Date | Jun 29, 2015 (initiated May 7, 2015) |
| Status | Terminated |
| Reason | Chest drains have a missing o-ring |
| Root cause | Process control |
| Action | Atrium Medical issued recall letter dated 5/7/15 to inform customers of the steps to take should they encounter affected product. If the O-ring is not present on the patient tubing: a. Do not use the chest drain. b. Replace the entire chest drain including the patient tubing. Open up another chest drain package and repeat steps 1 to 3. c. Return any units with missing O-rings to Atrium. If the O-ring is present then reconnect in-line connector and proceed with set up as normal. Complete and return Field Action Reply Form to the following e-mail address: connector@atriummed.com or you ma |
| Quantity | 390 cases |
| Distribution | Nationwide Canada, Germany |
| FDA record | Open on fda.gov |