Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retaine

FDA device recall Z-1852-2011 · posted 2011-03-30 · Terminated

Recall details

Recalling firm

Cardinal Health Inc

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)

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

NNI

Quantity affected

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,

Date initiated

2011-02-18

Date posted

2011-03-30

Date terminated

2011-10-04

Location

Dublin, OH