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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.

FDA Recall Z-0051-04 · Posted 2003-10-24

Recalling FirmPropper Mfg Co Inc
Recall StatusTerminated
Product CodeG-IO
Date Initiated2002-08-09
Date Terminated2003-10-23
Product Quantity178 boxes

Reason for Recall

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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