Recall Z-2574-2021 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Medline Industries Inc
NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold, On Star Handles, Ports on Right, Rx only, Sterile; (3) NAMIC Angiographic MANIFOLD High Pressure, REF 70037200, UPN H96570
| Date | Aug 6, 2021 |
| Status | Terminated |
| Reason | Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions. |
| Root cause | Process design |
| Action | The recalling firm issued letters dated and mailed on 8/6/2021 notifying consignees of the issue and requesting they immediately check their stock for the affected product and destroy it. |
| Quantity | 816,420 manifolds and stopcocks |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Australia, Japan, Latvia, Lebanon, Malaysia, Netherlands, Pakistan, People's Republic of China, Panama, Singapore, South Africa, South Korea, Thailand, and United Kingdom. |
| FDA record | Open on fda.gov |