BEUDAMED
    FDA Recall Terminated

    Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-01451-RH; PL-05041; PR-04041-HPX; PR-05041; PR-05041-HP; PR- 05041-HPX; PR-05041-LW; PR-05041-MW; PR-05041-T; PR-05042; PR-05541-HPX; PR-07041-PTSP; and RJ-01451-W.

    Recall: Z-1682-2010 · Initiated March 29, 2010

    Recall

    Recall Number
    Z-1682-2010
    Event Number
    55385
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 29, 2010
    Posted
    May 26, 2010
    Terminated
    September 27, 2012
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-01451-RH; PL-05041; PR-04041-HPX; PR-05041; PR-05041-HP; PR- 05041-HPX; PR-05041-LW; PR-05041-MW; PR-05041-T; PR-05042; PR-05541-HPX; PR-07041-PTSP; and RJ-01451-W.

    Reason

    Tight fit in sheath. Arrow has received complaints of the PICC catheter fitting too tightly in the "kit supplied" peelable sheath. In some cases, clinicians have been unable to insert the catheter through the peelable sheath during the insertion procedure. If the catheter will not pass through the sheath, the clinician is required to place a guide wire back into the sheath, remove the sheath, a

    Action

    Arrow International issued an Urgent Medical Device Recall letter dated 3/29/10 to inform their customers of the problem and the need to return the product.

    Distribution

    Worldwide distribution: USA, Australia, Brazil, Canada, New Zealand, Hong Kong, Malaysia, and Chile.

    Quantity

    6719