Recall Z-0051-04 ยท G-I
Propper Mfg Co Inc
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, re
| Date | Oct 24, 2003 (initiated Aug 9, 2002) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| 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. |
| Quantity | 178 boxes |
| Distribution | Distributors located in TX, UT, ID, IL, IA, IN, MN, WI, OH, CT, MO, PA, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.