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U.S. Department of Health and Human Services

Class 2 Device Recall PROGRESSIVE MEDICAL Laparoscopic Electrode

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 Class 2 Device Recall PROGRESSIVE MEDICAL Laparoscopic Electrodesee related information
Date Initiated by FirmFebruary 15, 2013
Date PostedMay 22, 2013
Recall Status1 Terminated 3 on August 07, 2013
Recall NumberZ-1347-2013
Recall Event ID 64618
510(K)NumberK962935 K970066 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductPROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.
Code Information Lot Numbers: 071212-02, 071212-03, 071212-05, 071212-01, 071212-06, 082712-02, 071212-04, 082712-04, 082712-05, 082712-13, 071212-07, 082712-07, 082712-09, 082712-03, 082712-15, 082712-14, 081712-06, 082712-01, 082712-10, 081512-06, 080612-01, 081512-07, 082712-12, 081512-04, 082712-11, 081012-01, 080612-03, 080612-02, 080612-04, 071612-05, 071612-04, 080612-05, 080612-07, 081312-11, 071612-03, 081312-10, 071912-01, 071912-02, 092812-02, 092812-03, 092812-04, 092812-05, 092812-06, 092812-07, 091312-01, 100812-02, 072312-01, 080612-08, 081312-01, 100112-01, 091312-04, 082312-04, 082312-03, 082312-06, 082312-05, 082812-02, 111212-01, 111212-03, 111212-02, 082312-02, 092812-02, 092812-07, 092812-06, 111212-19, 111212-18, 111212-18, 111212-19, 100212-01, 100312-06, 111212-11, 111212-07, 081512-05, 111212-04, 100312-01, 100312-03, 091312-02, 091312-03, 100312-08, 100312-09, 100312-10, 100312-01, 100312-03, 100312-04, 111212-14, 111212-10, 111212-08, 111212-07, 111212-17, 111212-20, 111212-21, 121012-03, 120612-01, 111212-12, 121012-01, 112112-01, 112112-02, 112112-03, 112112-04, 112112-06, 011113-04, 100312-02, 011013-10, 092812-01, 091912-02, 100312-05, 011013-12, 011013-05, 092812-02, 111212-16, 011013-04, 011013-07, 011013-08, 100312-13, 011013-02, 111212-09, 111212-11, 011013-11, 111212-13, 111212-15, 092812-03, 012213-02, 111212-12, 011013-13, 012213-01, 012213-04 011013-09, 011413-02, 012213-03, 011413-03, 011413-04, 111212-16, 011013-06, 012913-01, 012913-02, 111212-05, 012913-03, 012913-09, 012813-01. 
Recalling Firm/
Manufacturer		 Unimed Surgical Products, Inc.
10401 Belcher Rd S
Largo FL 33777-1415
For Additional Information ContactLee Alexander
727-546-1900
Manufacturer Reason
for Recall		Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.
FDA Determined
Cause 2		No Marketing Application
ActionUnimed Surgical Products, Inc. issued a Medical Device Correction and Removal letter dated February 15, 2013 to its customers. Customers were instructed to quarantine any undistributed product, and notify its customers of the recall to retrieve any unused product. For further information, contact Unimed Surgical Products Inc. at 1-800-531-2627.
Quantity in Commerce120,416 units
DistributionDistributed in the states of MO, TN, and PA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEI
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