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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 27, 2005
Date Posted June 25, 2005
Recall Status1 Terminated 3 on June 27, 2005
Recall Number Z-0932-05
Recall Event ID 32022
510(K)Number K042461  
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm on label: Tyco Healthcare, Mansfield, MA. Product sold sterile, 10 units per case.
Code Information 158125 and 158128
Recalling Firm/
Manufacturer		 Kendall Healthcare Products Co
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Marcus Gesner
508-261-6652
Manufacturer Reason
for Recall		 Holes in thermoformed tray compromising the sterility of the product.
FDA Determined
Cause 2		 Other
Action Visits by Tyco Sales Reps on 4/27 & 28/2005.
Quantity in Commerce 120 units
Distribution Product shipped to hospitals in AZ, CA, IL, IN, NY, and TX.
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 = LJS and Original Applicant = KENDALL
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