A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids.
FDA Recall Z-1268-2013 · Posted 2013-05-07
Advertisement
Reason for Recall
Firm Action
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement