Medline Industries Inc Recall 88516
Description: 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.
Medline Industries Inc Recall 88516 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2575-2021 |
| Event ID | 88516 |
| Event Description | 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. |
| Product Type | Devices |
| 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. |
| Quantity | 816,420 manifolds and stopcocks |
| Recall Reason | Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions. |
| Device Classification | 20211006 |
| Device 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. |
| Center Classification Date | 20210924 |
| Recall Initiation Date | 20210806 |
| Recalling Firm | Medline Industries Inc |
| Initial Notification | Letter |
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