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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

Product Description 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.
Recall Number Z-1268-2013
Classification Class II
Code Info A) Product Code 2N1191: Lots R12J06052, R12J08041, R12K06134, R12K08015, R12K26108, R12K27155; B) Product Code 2N1206: Lots R12J08124, R12J24121, R12K01119, R12K23089, R12K24053, R12K22016
Product Distributed Qty A) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 units
Reason For Recall Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

Event Detail

Event Id 64696
Product Type Devices
Status Ongoing
Recalling Firm Baxter Healthcare Corp.
City Deerfield
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.