Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-...

FDA Device Recall #Z-2575-2021 — Class II — August 6, 2021

Recall Summary

Recall Number Z-2575-2021
Classification Class II — Moderate risk
Date Initiated August 6, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medline Industries Inc
Location Northfield, IL
Product Type Devices
Quantity 816,420 manifolds and stopcocks

Product 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.

Reason for Recall

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

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.

Lot / Code Information

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.

Other Recalls from Medline Industries Inc

Recall # Classification Product Date
Z-0358-2022 Class II EVLP Convenience Pack/Kit Oct 27, 2021
Z-0362-2022 Class II Bedside PICC CDS Convenience Kit Oct 27, 2021
Z-0360-2022 Class II Major Vascular CDS Convenience Kit Oct 27, 2021
Z-0359-2022 Class II Neuro Convenience Kit Oct 27, 2021
Z-0361-2022 Class II Venous Access Pack-LF Convenience Kit Oct 27, 2021

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Medline Industries Inc Recalls by Firm Recall Reasons Device Safety Stats