# FDA recall Z-2575-2021

> **Medline Industries Inc** · Class II · device recall initiated 2021-08-06.

## 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 7003

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-2575-2021
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-06
- **Report date:** 2021-10-06
- **Termination date:** 2025-08-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2575-2021

## Citation

> AI Analytics. FDA recall Z-2575-2021. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2575-2021. Source: US FDA. Licensed CC0.

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