BEUDAMED
    FDA Recall Terminated

    Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7'' long Thoracentesis Catheter with a 14 gauge x 2'' needle, catheter guard, 60 ml syringe, needles, 5 ml syringe, drainage tube with needle, fluid collection bag, three prelabeled specimen vials with caps, 2 swab sticks, three gauze pads, fenestrated drape with adhesive strips, towel, 5 ml -1% lidocaine hydrochloride, hospital wrap and bandage; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA

    Recall: Z-0420-03 · Initiated November 15, 2002

    Recall

    Recall Number
    Z-0420-03
    Event Number
    25054
    Firm
    Cardinal Health 1430 Waukegan Rd ATTN: V. MUELLER QA McGaw Park IL 60085
    FEI Number
    3001236905
    Product Code
    GCB--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 15, 2002
    Posted
    January 9, 2003
    Terminated
    April 14, 2006

    Description

    Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7'' long Thoracentesis Catheter with a 14 gauge x 2'' needle, catheter guard, 60 ml syringe, needles, 5 ml syringe, drainage tube with needle, fluid collection bag, three prelabeled specimen vials with caps, 2 swab sticks, three gauze pads, fenestrated drape with adhesive strips, towel, 5 ml -1% lidocaine hydrochloride, hospital wrap and bandage; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA

    Reason

    Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use.

    Action

    Recall letters dated 11/15/02 were sent via 2-day FedEx to the direct accounts. The accounts were informed of the potential for breakage of the catheters during use, requested to inspect their inventories for the affected lot numbers, and segregate any found for return to Allegiance for replacement. Distributors were requested to sub-recall the product from their accounts. The recall was extended to include the 21 additional lots by letter dated 4/8/04. The letters were sent via Airborne Express, 1-Day, on 4/8/04. The instructions were the same as the 11/15/02 letter, except that Allegiance has changed their name to Cardinal Health.

    Distribution

    Nationwide distribution, including Puerto Rico and Guam, and internationally to Saudi Arabia

    Quantity

    232,228 trays