| Class 3 Device Recall MediVac Speciment Sock | |
Date Initiated by Firm | February 18, 2011 |
Date Posted | March 30, 2011 |
Recall Status1 |
Terminated 3 on October 04, 2011 |
Recall Number | Z-1852-2011 |
Recall Event ID |
58028 |
Product Classification |
Container, specimen, non-sterile - Product Code NNI
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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 OH 43017-1091
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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 | 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 |
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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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