FDA Device recall Z-2575-2021
NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, S…
- FDA Device
- Class II
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, S… by Medline Industries, citing potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2575-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-06 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries |
| Distribution | US |
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.
Reason
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Identifiers
| code_info | Expiration dates 12/31/2023-7/12/2024. (1) REF 70015002 - Lot numbers 0000002034, 0000004540, 0000004748, 0000004762,…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 number |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2575-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.