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U.S. Department of Health and Human Services

Class 2 Device Recall NonDEHP Catheter Extension Set

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  Class 2 Device Recall NonDEHP Catheter Extension Set see related information
Date Initiated by Firm March 28, 2013
Date Posted May 07, 2013
Recall Status1 Terminated 3 on July 31, 2017
Recall Number Z-1268-2013
Recall Event ID 64696
510(K)Number K811078  
Product Classification Set, administration, intravascular - Product Code FPA
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.
Code Information A) Product Code 2N1191: Lots R12J06052, R12J08041, R12K06134, R12K08015, R12K26108, R12K27155;   B) Product Code 2N1206: Lots R12J08124, R12J24121, R12K01119, R12K23089, R12K24053, R12K22016
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact
224-948-2000
Manufacturer 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.
FDA Determined
Cause 2		 Packaging process control
Action Baxter sent an "Urgent Product Notification" dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taked. Customers are advised to locate and remove all of the affected products from their inventory. If the products were further distributed, consigneees are requested to notify their customers of the recall. Products can be returned for credit by contacting Baxter. An acknowledgement form is required to be compelted by customers.
Quantity in Commerce A) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 units
Distribution Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = TRAVENOL LABORATORIES, S.A.
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