—#188974

Product

NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (3) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015012, UPN H965700150121, Four-way Stopcock with Rotating Collar, Rx only, Sterile; (4) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015013, UPN H965700150131, Four-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (5) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015015, UPN H965700150151, One-way Stopcock with Collar, Rx only, Sterile; (6) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035002, UPN H965700350021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (7) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035003, UPN H965700350031, Three-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (8) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035008, UPN H965700350081, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; (9) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035009, UPN H965700350091, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; (10) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055003, UPN H965700550031, Three-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (11) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055008, UPN H965700550081, Three-way Stopcock with Rotating Adapter, Rx only, Sterile; (12) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055009, UPN H965700550091, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; and (13) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055017, UPN H965700550171, One-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile.

FDA product code: DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K782095, K842829
Affected lot / code info: Expiration dates 12/31/2023-7/12/2024. (1) REF 70015002 - Lot numbers 0000002034, 0000004540, 0000004748, 0000004762, 0000005986, 0000006006, 0000008507, 0000008561, 0000010311, 0000011009, 0000011021, 0000012601, 0000012667, 0000013628, 0000013629, 0000014168, 0000015265, 0000015855, 0000016237, 0000017369; (2) REF 70015003 - Lot numbers 0000002035,0000004399, 0000004781, 0000004859, 0000005958, 0000014171, 0000015997; UPN H965700150031 - Lot number 5658899; (3) REF 70015012 - Lot numbers 0000012075, 0000013640, 0000015290; (4) REF 70015013 - Lot number 0000008503, UPN H965700150131 - Lot numbers 5656213, 5662009; (5) REF 70015015 - Lot numbers 0000005117, 0000007641, 0000007718, 0000011557, 0000014654, 0000017017; UPN H965700150151 - Lot numbers 5655470, 5656214, 5659327; (6) REF 70035002 - Lot numbers 0000002036, 0000002455, 0000008408, 0000008440, 0000008476, 0000010488, 0000015089, 0000017049; UPN H965700350021 - Lot numbers 5654454; 5656220; (7) REF 70035003 - Lot numbers 0000006313, 0000008178, 0000015121; (8) REF 70035008 - Lot numbers 0000003306, 0000010735, 0000014795, 0000016525; UPN H965700350081 - Lot numbers 5653290, 5656221; (9) REF 70035009 - Lot numbers 0000007115, 0000007611, 0000007616, 0000009644, 0000010737, 0000010748, 0000012633, 0000012634, 0000014808, 0000015019, 0000015024, 0000017448; UPN H965700350091 - Lot numbers 5653289, 5658896, 5659333, 5659887, 5659889; (10) REF 70055003 - Lot numbers 0000007025, 0000012635, 0000016518; UPN H965700550031 - Lot numbers 5653288, 5658901, 5662967; (11) REF 70055008 - Lot numbers 0000007081, 0000014807; UPN H965700550081 - Lot numbers 5653287, 5656299; (12) REF 70055009 - Lot numbers 0000003281, 0000003284, 0000007024, 0000007600, 0000007601, 0000009626, 0000009627, 0000010746, 0000012300, 0000012301, 0000012302, 0000014982, 0000015022, 0000016270, 0000016520; UPN H965700550091 - Lot numbers 5653286, 5657315, 5658895, 5658897, 5659900, 5659903, 5659905; and (13) REF 70055017 - Lot numbers 0000007147, 0000010747, 0000015023; UPN H965700550171 - Lot number 5661997.

Why it was recalled

Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-08-06
Terminated: 2025-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188974. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.