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U.S. Department of Health and Human Services

Class 3 Device Recall MediVac Speciment Sock

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 Class 3 Recall
MediVac Speciment Sock
see related information
Date Posted March 30, 2011
Recall Status1 Terminated on October 04, 2011
Recall Number Z-1852-2011
Recall Event ID 58028
Product Classification Container, Specimen, Non-Sterile - Product Code NNI
Product Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient. Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient.
Code Information 65652-123 and 65652-124 / 1091745
Recalling Firm/
Manufacturer
Cardinal Health Inc
7000 Cardinal Pl
Dublin, Ohio 43017-1091
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Troy Kirkpatrick
614-757-6225
Manufacturer Reason
for Recall
In one lot of product (lot# 1091745), the label for the small version of the sock (catalog number 65652-123) was improperly used for the larger version of the product (65652-124)
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action On February 18, 2011 Cardinal Health sent a consignee letter with the following instruction: 1) Quarantine either Catalog Number with the inticated Lot Number. 2) Contact the appropiate Customer Service group for return instructions: Hospital - 800-964-5227 Federal Government - 800-444-1166 Distributirs - 800-635-6021 All other customers - 888-444-5440 3) Return the enclosed acknowledge form via fax to 847-689-9101, even if you do not have affected product, as Cardinal Health is required to confirm receipt of this notification from you, and to prevent further notices. 4) Notify any customer to whom you may have distributed product affected by this recall.
Quantity in Commerce 3,360 each
Distribution Worldwide Distribution - USA including AL, AR, AZ. CA. CO,, CT, DC, DE, FL, GA, HI, IA, ID,IL,IM,KS, KY, LA, MA, MD, ME. MI MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico - and the country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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