Device product
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.
Z-1268-2013
Product summary
- Event
- Event 64696
- Status
- Terminated
- Classification
- Class II
- Quantity
- A) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 units
- Official record key
device-enforcement:Z-1268-2013
Official wording
Reason: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Code information: A) Product Code 2N1191: Lots R12J06052, R12J08041, R12K06134, R12K08015, R12K26108, R12K27155; B) Product Code 2N1206: Lots R12J08124, R12J24121, R12K01119, R12K23089, R12K24053, R12K22016
Distribution pattern: Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Derived failure modes
-
Unknown
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.