propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no. 043021, 6 Vi
FDA device recall Z-0051-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Propper Mfg Co Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- G-IO
- Quantity affected
- 178 boxes
- Distribution
- Distributors located in TX, UT, ID, IL, IA, IN, MN, WI, OH, CT, MO, PA, VA.
- Date initiated
- 2002-08-09
- Date posted
- 2003-10-24
- Date terminated
- 2003-10-23
- Location
- City, NY
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