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U.S. Department of Health and Human Services

Class 2 Device Recall NAMIC Manifolds

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  Class 2 Device Recall NAMIC Manifolds see related information
Date Initiated by Firm August 06, 2021
Create Date September 24, 2021
Recall Status1 Completed
Recall Number Z-2574-2021
Recall Event ID 88516
510(K)Number K782095  K842829  
Product Classification Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
Product 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 H965700372001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile;

(4) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037202, UPN H965700372021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile.

(5) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037301, UPN H965700373011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile;

(6) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037303, UPN H965700373031, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile;

(7) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038200, UPN H965700382001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile;

(8) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038202, UPN H965700382021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile;

(9) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038301, UPN H965700383011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile;

(10) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038303, UPN H96570038301, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile;

(11) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039202, UPN H965700392021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile;

(12) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039301, UPN H965700393011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; and

(13) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039303, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile.
Code Information Expiration dates 12/31/2023-6/30/2024. (1) REF 64038301 - Lot numbers 0000006342, 0000008482, 0000016519; UPN H965640383011 - Lot number 5642413; (2) REF 64038303 - Lot numbers 0000010144, 0000014189, 0000016524; UPN H965640383031 - Lot number 5642416; (3) REF 70037200 - Lot numbers 0000002033, 0000008570, 0000016521; UPN H965700372001 - Lot numbers 5649219, 5659335; (4) REF 70037202 - Lot numbers 0000014365, 0000016522; UPN H965700372021 - Lot numbers 5642417, 5642565, 5642566, 5642567, 5642568, 5643626, 5647596; (5) REF 70037301 - Lot numbers 0000002024, 0000006320, 0000010129; UPN H965700373011 - Lot number 5662011; (6) REF 70037303 - Lot numbers 0000002051, 0000006046; UPN H965700373031 - Lot numbers 5655475, 5662957, 5664026; (7) REF 70038200 - Lot numbers 0000001974, 0000006032, 0000010140, 0000014125; UPN H965700382001 - Lot numbers 5645162, 5649221, 5662013; (8) REF 70038202 - Lot numbers 0000007917, 0000010149, 0000016523; UPN H965700382021 - Lot numbers 5642414, 5649222, 5657918, 5660843; (9) REF 70038301 - Lot numbers 0000006189, 0000010147; UPN H965700383011 - Lot numbers 5642415, 5648171, 5649224, 5652296; (10) REF 70038303 - Lot numbers 0000006240, 0000008481, 0000010133, 0000010142, 0000014338; UPN H96570038301 - Lot numbers 5649225, 5650868; (11) REF 70039202 - Lot number 0000006312; UPN H965700392021 - Lot number 5662961; (12) REF 70039301 - Lot number 0000006055; UPN H965700393011 - Lot numbers 5642420, 5643629, 5652297, 5658658, 5662016; and (13) REF 70039303 - Lot number 0000016625.
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Ms. Karin Johnson
866-359-1704
Manufacturer Reason
for Recall		 Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTL and Original Applicant = NAMIC
510(K)s with Product Code = DTL and Original Applicant = NORTH AMERICAN INSTRUMENT CORP.
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