BEUDAMED
    FDA Recall Terminated

    propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1.40-1.75mm. O.D. Calibrated 60mm from end for use in direct reading centrifuges. Fill to the 60mm mark with blood and seal opposite end by flame or with sealing compound. If centrifuged on a direct reading centrifuge, read percent hematocrit directly from scale on the centrifuge. Otherwise, read in normal manner as a percent ratio of packed cells with 60mm of sample as 100%. Firm on label: propper manufacturing co., inc., long island city, n.y. 11101.

    Recall: Z-0051-04 · Initiated August 9, 2002

    Recall

    Recall Number
    Z-0051-04
    Event Number
    26844
    Firm
    Propper Mfg Co Inc
    FEI Number
    2410251
    Product Code
    G-IO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 9, 2002
    Posted
    October 24, 2003
    Terminated
    October 23, 2003
    Address
    36-04 Skillman Avenue, Long Island City, NY, 11101

    Description

    propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1.40-1.75mm. O.D. Calibrated 60mm from end for use in direct reading centrifuges. Fill to the 60mm mark with blood and seal opposite end by flame or with sealing compound. If centrifuged on a direct reading centrifuge, read percent hematocrit directly from scale on the centrifuge. Otherwise, read in normal manner as a percent ratio of packed cells with 60mm of sample as 100%. Firm on label: propper manufacturing co., inc., long island city, n.y. 11101.

    Reason

    Deviation in capillary tubes could cause a 10% increase in read out values which could make a slight anemic patient appear to have a normal reading.

    Action

    On 8/9/02, Propper faxed a 'Request for Return' of the product to the consignees advising them of the problem and that a replacement will be sent for all returned product. On 11/27/02, Propper faxed a second 'Request for Return of Product' to its consignees. The firm destroyed the recovered and held stock.

    Distribution

    Distributors located in TX, UT, ID, IL, IA, IN, MN, WI, OH, CT, MO, PA, VA.

    Quantity

    178 boxes