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U.S. Department of Health and Human Services

Class 2 Device Recall SCD Express; VasoForce; Benaflow

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  Class 2 Device Recall SCD Express; VasoForce; Benaflow see related information
Date Initiated by Firm May 03, 2013
Date Posted July 01, 2013
Recall Status1 Terminated 3 on July 11, 2013
Recall Number Z-1638-2013
Recall Event ID 65205
510(K)Number K012658  
Product Classification Sleeve, limb, compressible - Product Code JOW
Product - Calf Garment Standard Ref. L501-M Lot 122549, 122985

- Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546

- Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570

- SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574

- SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574

- SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574
Compressible limb sleeve.

- Thigh Garment DVT30 Medium Ref. DVT30 Lot 122549, 122985

- Thigh Garment DVT40 Large Ref. DVT40 Lot 122549, 122985

- Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24" 24" Ref. MDS601L Lot 122982, 122986

- Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18" 18" Ref. MDS601M Lot 122986, 122984

- VENAFLOW Calf Cuff, w/Foam (White) 19" Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715
Code Information 122692, 122982, 122986, 122984, 122549, 122985, 122570, 122546, 122547, 122574, 122715.
Recalling Firm/
Manufacturer		 Surgical Instrument Service And Savings, Inc.
2747 Sw 6th St
Redmond OR 97756-7109
For Additional Information Contact Rich Wynkoop
866-866-7477
Manufacturer Reason
for Recall		 The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
FDA Determined
Cause 2		 Packaging process control
Action MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.
Quantity in Commerce 229
Distribution Nationwide Distribution.
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 = JOW and Original Applicant = SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
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