Class 3 Device Recall Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray

• Date Initiated by Firm: September 15, 2005
• Date Posted: October 28, 2005
• Recall Status: Terminated on November 22, 2005
• Recall Number: Z-0103-06
• Recall Event ID: 33789
• 510(K)Number: K003682
• Product Classification: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
• Product: Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T
• Code Information: Lot number MABY360
• FEI Number: 2518902
• Recalling Firm/ Manufacturer: Medical Components, Inc dba MedComp; 1499 Delp Dr; Harleysville PA 19438-2936
• For Additional Information Contact: Susan Smith, RN; 215-256-4201
• Manufacturer Reason for Recall: The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F
• FDA Determined Cause: Other
• Action: On 9/15/05, the recalling firm telephoned the two distributors to inform them of the problem and the need to return the product.
• Quantity in Commerce: 10 units
• Distribution: The products were shipped to distributors in OH and MO.
• 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