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.
This recall has been terminated (originally issued October 24, 2003).
- Company
- Propper Mfg Co Inc
- Recall Initiated
- August 9, 2002
- Posted
- October 24, 2003
- Terminated
- October 23, 2003
- Recall Number
- Z-0051-04
- Quantity
- 178 boxes
- Firm Location
- Long Island City, NY
- Official Source
- View on FDA website ↗
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.
Distribution
Distributors located in TX, UT, ID, IL, IA, IN, MN, WI, OH, CT, MO, PA, VA.
Lot / Code Info
Reorder No. 043021, Lot # C0402
Root Cause
Other
Action Taken
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.