Recall Z-1852-2011 ยท NNI Container, Specimen, Non-Sterile
Cardinal Health Inc
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
| Date | Mar 30, 2011 (initiated Feb 18, 2011) |
| Status | Terminated |
| Reason | 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) |
| Root cause | 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 custome |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.