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Class 2 Device Recall CareFusion |
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| Date Initiated by Firm |
May 30, 2014 |
| Date Posted |
September 30, 2014 |
| Recall Status1 |
Terminated 3 on November 29, 2017 |
| Recall Number |
Z-2724-2014 |
| Recall Event ID |
68725 |
| 510(K)Number |
K060232
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| Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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| Product |
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. |
| Code Information |
1) Instrumed Item No.: 250-08570; CareFusion Catalog Code: VM46-9112-1; Lot Number: 010111; 2) Instrumed Item No.: 250-08600; CareFusion Catalog Code: LA8523 ; Lot Number: 070211, 070213, 090412; 3) Instrumed Item No.: 250-08610; CareFusion Catalog Code: LA8523-45; Lot Number: 042011, 062209; 4) Instrumed Item No.: 250-08620; CareFusion Catalog Code: LA8515; Lot Number: 030511, 040310, 080111; 5) Instrumed Item No.: 250-08630; CareFusion Catalog Code: LA8515-45; Lot Number: 050212; 6) Instrumed Item No.: 250-08660; CareFusion Catalog Code: LA8514; Lot Number: 040110; 7) Instrumed Item No.: 250-08670; CareFusion Catalog Code: LA8514-45; Lot Number: 120410; 8) Instrumed Item No.: 250-08680; CareFusion Catalog Code: LA8526; Lot Number: 010313, 060311, 060312; 9) Instrumed Item No.: 250-08690; CareFusion Catalog Code: LA8526-45; Lot Number: 030314, 100410, 120110, 120312; 10) Instrumed Item No.: 250-08700; CareFusion Catalog Code: LA8518; Lot Number: 060111, 070110, 080211; 11) Instrumed Item No.: 250-08710; CareFusion Catalog Code: LA8518-45; Lot Number: 010114, 040113, 040313, 060410; 12) Instrumed Item No.: 250-08730; CareFusion Catalog Code: LA8520-45; Lot Number: 010213; 13) Instrumed Item No.: 250-08740; CareFusion Catalog Code: LA8519; Lot Number: 060108, 080310; 14) Instrumed Item No.: 250-08760; CareFusion Catalog Code: LA8521; Lot Number: 020212, 060113, 060213, 100513, 121410; 15) Instrumed Item No.: 250-08770; CareFusion Catalog Code: LA8521-45; Lot Number: 100210; 16) Instrumed Item No.: 250-08780; CareFusion Catalog Code: LA8513; Lot Number: 010110, 050313, 070112, 122110; 17) Instrumed Item No.: 250-08790; CareFusion Catalog Code: LA8513-45; Lot Number: 090411, 100309, 100312; 18) Instrumed Item No.: 250-08800; CareFusion Catalog Code: LA8525; Lot Number: 040114, 090410, 110310, 120111; 19) Instrumed Item No.: 250-08810; CareFusion Catalog Code: LA8525-45; Lot Number: 050308, 060310; 20) Instrumed Item No.: 250-08820; CareFusion Catalog Code: LA8517; Lot Number: 110410, 120212; 21) Instrumed Item No.: 250-08860; CareFusion Catalog Code: LA8507; Lot Number: 011111, 020111, 030210, 041411, 060112, 060313, 070312, 070712, 100413, 100512, 110112, 110313, 110413; 22) Instrumed Item No.: 250-08880; CareFusion Catalog Code: LA8507-45; Lot Number: 061011, 070313, 070513; 23) Instrumed Item No.: 250-08890; CareFusion Catalog Code: LA8506; Lot Number: 020211, 020410; 24) Instrumed Item No.: 250-08900; CareFusion Catalog Code: LA8506-45; Lot Number: 050407; 25) Instrumed Item No.: 250-08930; CareFusion Catalog Code: LA8505; Lot Number: 010314, 010513, 010611, 030113, 032211, 040112, 090313, 100111, 120710; 26) Instrumed Item No.: 250-08960; CareFusion Catalog Code: LA8505-45; Lot Number: 30313, 090113, 110110, 120211; 27) Instrumed Item No.: 250-08970; CareFusion Catalog Code: LA8504; Lot Number: 050110, 080510; 28) Instrumed Item No.: 250-08980; CareFusion Catalog Code: LA8504-45; Lot Number: 050311; 29) Instrumed Item No.: 250-08990; CareFusion Catalog Code: LA8503; Lot Number: 020414, 042310, 110411; 30) Instrumed Item No.: 250-09000; CareFusion Catalog Code: LA8503-45; Lot Number: 020512; 31) Instrumed Item No.: 250-09010; CareFusion Catalog Code: LA8509; Lot Number: 020413, 021511, 030211, 030212, 030G12, 03101816-; 32) Instrumed Item No.: 250-09030; CareFusion Catalog Code: LA8509-45; Lot Number: 070212; 33) Instrumed Item No.: 250-09040; CareFusion Catalog Code: LA8510; Lot Number: 040411; 34) Instrumed Item No.: 250-09070; CareFusion Catalog Code: LA8508-45; Lot Number: 050410; 35) Instrumed Item No.: 250-09100; CareFusion Catalog Code: VM46-9183; Lot Number: 060411; 36) Instrumed Item No.: 250-09120; CareFusion Catalog Code: VM46-9185; Lot Number: 090308 |
Recalling Firm/
Manufacturer |
Instrumed International, Inc.
626 Cooper Ct
Schaumburg IL 60173-4537
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| For Additional Information Contact |
Ms. Jennifer Staunton
847-908-6119
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Manufacturer Reason
for Recall |
Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
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FDA Determined
Cause 2 |
Labeling design |
| Action |
Instrumed sent an URGENT: MEDICAL DEVICE CORRECTION letters dated May 30, 2014 to all consignees. The letters advised the consignees of the new warning statements on the product Instructions For Use and an instruction to complete and return the attached Response Request Form to Instrumed International. Consignees were further instructed to extend the recall to the retail level. For questions contact Instrumed Quality Manager at 847-908-6119. |
| Quantity in Commerce |
3,093 instruments |
| Distribution |
Distribution US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. |
| Total Product Life Cycle |
TPLC Device Report
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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.
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| 510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = TROKAMED GMBH
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