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

Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters ...

FDA Device Recall #Z-2661-2014 — Class II — September 4, 2014

Recall Summary

Recall Number Z-2661-2014
Classification Class II — Moderate risk
Date Initiated September 4, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Teleflex Medical
Location Research Triangle Park, NC
Product Type Devices
Quantity 193,363 ea. + 1,140 units (total 194,503 units)

Product Description

Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.

Reason for Recall

Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Bahrain, Belgrad, Canada, Croatia, Cypress, Czeck Republic, Denmark, Finland, Germany, Great Britain, Hungary, Ireland, Italy, Libya, Netherlands, Norway, Romania, Russia, Saudi Arabia, Slavonia, Slovakia, Spain, Switzerland, Turkey, Portugal and Zambia.

Lot / Code Information

Product Code #402100060, Lot #13491 & 13501; Product Code #402140120, Lot #13371, 13391 & 13511; Product Code #401140140, 13501, 14091, 14141, 13271, 13461, 13481, 14061, 14081 & 14101; Product Code #402140160, Lot #13411, 13291, 13311, 13301, 13391 & 13491; Product Code #402140240, Lot #13311 & 13391; Product Code #403300100, Lot #13311, 13411, 13461, 13481, 14041, 14091 & 14131; Product Code #403340140, Lot #13291; Product Code #403900080, Lot #13371 & 13411; Product Code #403900100, Lot #13261 & 13441; Product Code #403900120, Lot #13351, 13451, 13511 & 13461 and Product Code #410200200, Lot #13411. On 1/9/2015 recall expanded to include: Product Code: 40214-000080, Lot numbers 14101 & 13301; Product Code: 402140-000140, Lot number: 14281; Product Code: 402140-0001160, Lot number: 13491; Product Code: 402140-000180, Lot number: 13391 and Product Code; 402140-000240, Lot numbers: 13391 & 14027.

Other Recalls from Teleflex Medical

Recall # Classification Product Date
Z-0703-2020 Class II HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial ... Oct 30, 2019
Z-0688-2020 Class II Arrow EZ-IO Intraosseous Vascular Access System... Oct 8, 2019
Z-0689-2020 Class II Arrow EZ-IO Intraosseous Vascular Access System... Oct 8, 2019
Z-0690-2020 Class II Arrow EZ-IO Intraosseous Vascular Access System... Oct 8, 2019
Z-0496-2020 Class II WECK AutoEndo5, Automatic Hem-O-Lok Clip Applie... Oct 4, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

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 Teleflex Medical Recalls by Firm Recall Reasons Device Safety Stats