Data Foundry

Medical device recalls 2021

NAMIC Stopcocks: — Class II medical device recall Z-2575-2021

Terminated recall by Medline Industries Inc, reported 2021-10-06, distributed nationwide. Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to

Recall numberZ-2575-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMedline Industries Inc, Northfield, IL, United States
Recall initiated2021-08-06
Classified2021-09-24
Reported by FDA2021-10-06
Terminated2025-08-25
DistributedNationwide (US)
Countries outside the USAU, CA, CN, GB, JP, KR, LB, LV, MY, NL, PA, PK, SG, TH, ZA
Quantity816,420 manifolds
Reason classessterility
UPC / GTIN / UDI-DI00965700150021, 00965700150151, 00965700550081
Lot numbers0000002034, 0000002035, 0000002036, 0000002455, 0000003281, 0000003284, 0000003306, 0000004399, 0000004540, 0000004748, 0000004762, 0000004781, 0000004859, 0000005117, 0000005958, 0000005986, 0000006006, 0000006313, 0000007024, 0000007025, 0000007081, 0000007115, 0000007147, 0000007600, 0000007601, 0000007611, 0000007616, 0000007641, 0000007718, 0000008178, 0000008408, 0000008440, 0000008476, 0000008503, 0000008507, 0000008561, 0000009626, 0000009627, 0000009644, 0000010311 and 85 more
Model numbers70015002, 70015003, 70015012, 70015013, 70015015, 70035002, 70035003, 70035008, 70035009, 70055003, 70055008, 70055009, 70055017, H965700150021, H965700150031, H965700150121, H965700150131, H965700150151, H965700350021, H965700350031, H965700350081, H965700350091, H965700550031, H965700550081, H965700550091 and 1 more
Expiration dates2023-12-31

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 for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2575-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.