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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68725

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 30, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Instrumed International, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

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.

Z-2721-2014
Recall number
Z-2721-2014
Initiated
May 30, 2014
Classification
Class II
Status
Terminated
Quantity
65 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Instrumed Item No.: 250-08800; Adler Instrument Company Catalog Code: 70-0300; Lot Number: 070113; 2) Instrumed Item No.: 250-08860 ; Adler Instrument Company Catalog Code: 70-0319; Lot Number: 030312, 070411; 3) Instrumed Item No.: 250-08930; Adler Instrument Company Catalog Code: 70-0318; Lot Number: 010113, 020113, 030112, 050412, 060413, 070512, 090213, 100113, 100411; 4) Instrumed Item No.: 250-08960 ; Adler Instrument Company Catalog Code: AD98-1008; Lot Number: 090310; 5) Instrumed Item No.: 250-09010 ; Adler Instrument Company Catalog Code: 70-0317; Lot Number: 100211

Distribution pattern

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.

device · product 2 of 10

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.

Z-2722-2014
Recall number
Z-2722-2014
Initiated
May 30, 2014
Classification
Class II
Status
Terminated
Quantity
2 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Instrumed Item No.: 250-08930; Ambler Surgical Corporation Catalog Code: J647-6; Lot Number: 060412;

Distribution pattern

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.

device · product 3 of 10

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.

Z-2723-2014
Recall number
Z-2723-2014
Initiated
May 30, 2014
Classification
Class II
Status
Terminated
Quantity
156 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Instrumed Item No.: 250-08680; Boss Instruments Catalog Code: 35-8015; Lot Number: 030411, 100110, 110210; 2) Instrumed Item No.: 250-08700; Boss Instruments Catalog Code: 35-8016; Lot Number: 030111; 3) Instrumed Item No.: 250-08700; Boss Instruments Catalog Code: 35-8016; Lot Number: 30111; 4) Instrumed Item No.: 250-08760; Boss Instruments Catalog Code: 35-8020; Lot Number: 020411, 070111, 100412, 110412; 5) Instrumed Item No.: 250-08770; Boss Instruments Catalog Code: 35-8020L; Lot Number: 020112, 110211, 120310; 6) Instrumed Item No.: 250-08800; Boss Instruments Catalog Code: 35-8025; Lot Number: 060110, 100112; 7) Instrumed Item No.: 250-08820; Boss Instruments Catalog Code: 35-8026 ; Lot Number: 032811; 8) Instrumed Item No.: 250-08860; Boss Instruments Catalog Code: 35-8030; Lot Number: 050413, 070412, 110510, 090110; 9) Instrumed Item No.: 250-08880; Boss Instruments Catalog Code: 35-8030L; Lot Number: 090110; 10) Instrumed Item No.: 250-08890; Boss Instruments Catalog Code: 35-8035; Lot Number: 100213; 11) Instrumed Item No.: 250-08930; Boss Instruments Catalog Code: 35-8040; Lot Number: 010211, 020213, 020811, 021711, 040212, 040311, 080212, 100310, 110113, 120413; 12) Instrumed Item No.: 250-08960; Boss Instruments Catalog Code: 35-8040L; Lot Number: 030413, 040412, 040513, 120113; 13) Instrumed Item No.: 250-08990; Boss Instruments Catalog Code: 35-8042; Lot Number: 050312; 14) Instrumed Item No.: 250-09000; Boss Instruments Catalog Code: 35-8042L; Lot Number: 100406; 15) Instrumed Item No.: 250-09010; Boss Instruments Catalog Code: 35-8045; Lot Number: 010311, 020311, 090312, 100212, 120112, 120213

Distribution pattern

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.

device · product 4 of 10

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.

Z-2724-2014
Recall number
Z-2724-2014
Initiated
May 30, 2014
Classification
Class II
Status
Terminated
Quantity
3,093 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

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.

device · product 5 of 10

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.

Z-2725-2014
Recall number
Z-2725-2014
Initiated
May 30, 2014
Classification
Class II
Status
Terminated
Quantity
83 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Instrumed Item No.: 250-08930; Pilling Weck Inc. / Teleflex Medical Catalog Code: 728163; Lot Number: 66745

Distribution pattern

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.

device · product 6 of 10

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.

Z-2726-2014
Recall number
Z-2726-2014
Initiated
May 30, 2014
Classification
Class II
Status
Terminated
Quantity
122 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Instrumed Item No.: 250-08930; Specialty Care Catalog Code: 30-92221; Lot Number: 040413

Distribution pattern

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.

device · product 7 of 10

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.

Z-2727-2014
Recall number
Z-2727-2014
Initiated
May 30, 2014
Classification
Class II
Status
Terminated
Quantity
895 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Instrumed Item No.: 250-08860; Symmetry Surgical Inc. Catalog Code: 90-9525; Lot Number: 030214; 2) Instrumed Item No.: 250-08930; Symmetry Surgical Inc. Catalog Code: 90-9522; Lot Number: 070511; 3) Instrumed Item No.: 250-08990; Symmetry Surgical Inc. Catalog Code: 90-9526; Lot Number: 031511; 4) Instrumed Item No.: 250-09010; Symmetry Surgical Inc. Catalog Code: 90-9523; Lot Number: 080112

Distribution pattern

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.

device · product 8 of 10

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.

Z-2728-2014
Recall number
Z-2728-2014
Initiated
May 30, 2014
Classification
Class II
Status
Terminated
Quantity
71 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Instrumed Item No.: 250-09010; Phoenix Instruments Catalog Code: 190-9523; Lot Number: 070411; 2) Instrumed Item No.: 250-09040; Phoenix Instruments Catalog Code: 190-9527; Lot Numbers: 010211, 040411

Distribution pattern

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.

device · product 9 of 10

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.

Z-2729-2014
Recall number
Z-2729-2014
Initiated
May 30, 2014
Classification
Class II
Status
Terminated
Quantity
15 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Number: 070512; 2) Instrumed Item No.: 250-08700; Surgical Direct Catalog Code: SD11451.140; Lot Number: 080211; 3) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Numbers: 030112, 080212, 010113, 020113; 4) Instrumed Item No.: 250-08960; Surgical Direct Catalog Code: SD17520045.100; Lot Number: 070412; 5) Instrumed Item No.: 250-089360; Surgical Direct Catalog Code: SD175200.100; Lot Number: 030413

Distribution pattern

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.

device · product 10 of 10

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.

Z-2730-2014
Recall number
Z-2730-2014
Initiated
May 30, 2014
Classification
Class II
Status
Terminated
Quantity
2 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Instrumed Item No.: 250-08660; Surgimed - MLB Catalog Code: 91-112; Lot Numbers: 040110, 100112

Distribution pattern

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.